Assura
Alterna Protective Seal / Assura Protective Seal / Alterna ostomy pouch / Assura Ostomy pouch. 1-Piece closed, with filter. Opaque. Mini. Mini. Base Plate Precut Start Hole Size 20 mm, Base…
Alterna Protective Seal / Assura Protective Seal / Alterna ostomy pouch / Assura Ostomy pouch. 1-Piece closed, with filter. Opaque. Mini. Mini. Base Plate Precut Start Hole Size 20 mm, Base Plate Max Cut Size 65 mm, Base Plate Type Flat.
18manufacturers in China registered for this device type
252catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (4), Shanghai (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Shaoxing Haoshide Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 18. All 18 manufacturers in China registered for Collector, Ostomy
Record
| Listed by | Coloplast A/S, Denmark |
|---|---|
| FDA product code | EXB |
| Device type | Collector, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-02 |
| Record revised | 2023-10-12 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: This way up. Do not use if package is damaged and consult IFU. |
| Packaging | Shipper box of 30, shipper box of 10, shipper box of 16, shipper box of 20, shipper box of 12, retail box of 5 |
| Sizes | Lumen/inner diameter 40 to 60 mm; total volume 530 to 655 ml |
| Distribution end date | 2024-07-10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2833 | Coupling Size Diameter – in 2 3/8 | 5 | In distribution |
| 13625 | Base Plate Precut Start Hole Size – mm 10 | In distribution | |
| 15976 | Lumen/Inner Diameter 60 mm | 10 | In distribution |
| 12385 | Coupling Size Diameter – in 1 15/16 | 30 | In distribution |
| 2115 | Base Plate Type Flat | 10 | In distribution |
| 2161 | Descriptive Bag Size Pediatric | 30 | In distribution |
| 14275 | Lumen/Inner Diameter 50 mm | 5 | In distribution |
| 13985 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14692 | 10 | In distribution | |
| 12110 | Base Plate Precut Start Hole Size – mm 20 | 30 | In distribution |
| 14421 | Base Plate Type Convex Light | 10 | In distribution |
| 14227 | Coupling Size Diameter – in 1 9/16 | 10 | In distribution |
| 12577 | Descriptive Bag Size Maxi | 10 | In distribution |
| 12845 | Base Plate Max Cut Size – in 1 3/4 | 5 | In distribution |
| 14423 | Base Plate Precut Start Hole Size – mm 28 | 10 | In distribution |
| 12354 | Descriptive Bag Size Midi | 30 | In distribution |
| 14292 | Lumen/Inner Diameter 40 mm | 5 | In distribution |
| 12703 | Base Plate Type Convex | 5 | In distribution |
| 12716 | Base Plate Precut Start Hole Size – mm 15 | 5 | In distribution |
| 14431 | Base Plate Type Convex Light | 10 | In distribution |
| 12630 | 10 | In distribution | |
| 15860 | Base Plate Precut Start Hole Size – mm 12 | 10 | In distribution |
| 13976 | Lumen/Inner Diameter 60 mm | 10 | In distribution |
| 12345 | Lumen/Inner Diameter 50 mm | 30 | In distribution |
| 14228 | Coupling Size Diameter – in 1 15/16 | 10 | In distribution |
| 14441 | Base Plate Precut Start Hole Size – in 9/16 | 10 | In distribution |
| 13875 | Base Plate Precut Start Hole Size – mm 30 | 10 | In distribution |
| 14415 | Base Plate Max Cut Size – in 1 11/16 | 10 | In distribution |
| 14235 | Base Plate Precut Start Hole Size – in 1 1/8 | 5 | In distribution |
| 1757 | Coupling Size Diameter – in 1 9/16 | 10 | In distribution |
| 14174 | Descriptive Bag Size Maxi | 10 | In distribution |
| 13844 | Descriptive Bag Size Midi | 10 | In distribution |
| 14205 | 10 | In distribution | |
| 12144 | Base Plate Precut Start Hole Size – mm 25 | 30 | In distribution |
| 12384 | Lumen/Inner Diameter 40 mm | 30 | In distribution |
| 13974 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14274 | Base Plate Type Convex Light | 5 | In distribution |
| 1751 | Lumen/Inner Diameter 40 mm | 10 | In distribution |
| 12847 | Lumen/Inner Diameter 60 mm | 5 | In distribution |
| 1789 | Lumen/Inner Diameter 40 mm | 10 | In distribution |
| 14682 | 10 | In distribution | |
| 12533 | 10 | In distribution | |
| 1755 | Coupling Size Diameter – in 1 15/16 | 10 | In distribution |
| 12433 | Descriptive Bag Size Maxi | 10 | In distribution |
| 15983 | Descriptive Bag Size Maxi | 10 | In distribution |
| 15974 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14296 | Base Plate Type Convex Light | 5 | In distribution |
| 14234 | Lumen/Inner Diameter 50 mm | 5 | In distribution |
| 12800 | Base Plate Max Cut Size – in 2 3/4 | In distribution | |
| 12146 | Descriptive Bag Size Midi | 30 | In distribution |
| 14297 | Coupling Size Diameter – in 2 3/8 | 5 | In distribution |
| 14103 | Base Plate Type Convex | 10 | In distribution |
| 12994 | Base Plate Precut Start Hole Size – mm 25 | 10 | In distribution |
| 14444 | Base Plate Precut Start Hole Size – in 9/16 | 10 | In distribution |
| 12802 | Base Plate Max Cut Size – in 3 15/16 | In distribution | |
| 12844 | Base Plate Precut Start Hole Size – mm 30 | 5 | In distribution |
| 12176 | Descriptive Bag Size Maxi | 30 | In distribution |
| 2883 | Base Plate Precut Start Hole Size – mm 10 | 5 | In distribution |
| 14411 | Base Plate Type Convex Light | 10 | In distribution |
| 12578 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14196 | Base Plate Precut Start Hole Size – in 9/16 | 10 | In distribution |
| 13874 | Descriptive Bag Size Maxi | 10 | In distribution |
| 13703 | Base Plate Type Convex | 10 | In distribution |
| 12140 | Descriptive Bag Size Midi | 30 | In distribution |
| 12842 | Lumen/Inner Diameter 40 mm | 5 | In distribution |
| 14229 | Coupling Size Diameter – in 2 3/8 | 10 | In distribution |
| 12705 | Base Plate Max Cut Size – mm 33 | 5 | In distribution |
| 14445 | Descriptive Bag Size Maxi | 10 | In distribution |
| 8009 | Base Plate Precut Start Hole Size – mm 10 | 10 | In distribution |
| 12356 | Coupling Size Diameter – in 2 3/8 | 30 | In distribution |
| 13620 | Total Volume 655 ml | In distribution | |
| 12670 | 10 | In distribution | |
| 14236 | Lumen/Inner Diameter 50 mm | 5 | In distribution |
| 14273 | Lumen/Inner Diameter 50 mm | 5 | In distribution |
| 13965 | Coupling Size Diameter – in 1 15/16 | 10 | In distribution |
| 8116 | Descriptive Bag Size Magnum | 10 | In distribution |
| 14295 | Base Plate Type Convex Light | 5 | In distribution |
| 12134 | Base Plate Max Cut Size – mm 65 | 30 | In distribution |
| 1752 | Descriptive Bag Size Midi | 10 | In distribution |
| 12707 | Base Plate Max Cut Size – mm 43 | 5 | In distribution |
| 14263 | Base Plate Max Cut Size – in 1 11/16 | 5 | In distribution |
| 14163 | Base Plate Precut Start Hole Size – in 13/16 | 10 | In distribution |
| 13975 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14165 | Base Plate Precut Start Hole Size – in 1 1/8 | 10 | In distribution |
| 12527 | Coupling Size Diameter – in 1 9/16 | 10 | In distribution |
| 12996 | Descriptive Bag Size Maxi | 10 | In distribution |
| 12997 | Base Plate Precut Start Hole Size – in 1 3/8 | 10 | In distribution |
| 13966 | Descriptive Bag Size Midi | 10 | In distribution |
| 14272 | Base Plate Type Convex Light | 5 | In distribution |
| 12528 | Lumen/Inner Diameter 50 mm | 10 | In distribution |
| 2837 | Lumen/Inner Diameter 60 mm | 5 | In distribution |
| 5585 | Base Plate Type Flat | 10 | In distribution |
| 12145 | Base Plate Max Cut Size – mm 65 | 30 | In distribution |
| 14278 | Base Plate Max Cut Size – mm 43 | 5 | In distribution |
| 12810 | Base Plate Max Cut Size – mm 100 | In distribution | |
| 14251 | Base Plate Precut Start Hole Size – mm 20 | 5 | In distribution |
| 14164 | Descriptive Bag Size Maxi | 10 | In distribution |
| 2847 | Coupling Size Diameter – in 2 3/8 | 10 | In distribution |
| 12995 | Base Plate Type Convex | 10 | In distribution |
| 14294 | Base Plate Precut Start Hole Size – in 1 1/8 | 5 | In distribution |
| 13840 | Base Plate Precut Start Hole Size – in 1/2 | 10 | In distribution |
| 14298 | Coupling Size Diameter – in 2 3/8 | 5 | In distribution |
| 14204 | 10 | In distribution | |
| 14237 | Coupling Size Diameter – in 2 3/8 | 5 | In distribution |
| 14166 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14232 | Base Plate Max Cut Size – mm 23 | 5 | In distribution |
| 8114 | Descriptive Bag Size Magnum | 10 | In distribution |
| 14233 | Lumen/Inner Diameter 40 mm | 5 | In distribution |
| 2501 | Base Plate Precut Start Hole Size – in 13/16 | 30 | In distribution |
| 15986 | Descriptive Bag Size Maxi | 10 | In distribution |
| 15975 | Lumen/Inner Diameter 50 mm | 10 | In distribution |
| 14206 | 10 | In distribution | |
| 13984 | Lumen/Inner Diameter 40 mm | 10 | In distribution |
| 2802 | Coupling Size Diameter – in 1 15/16 | 30 | In distribution |
| 14282 | Base Plate Max Cut Size – mm 33 | 5 | In distribution |
| 5580 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14175 | Base Plate Precut Start Hole Size – mm 28 | 10 | In distribution |
| 1758 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14176 | Base Plate Type Convex | 10 | In distribution |
| 12702 | Base Plate Max Cut Size – mm 23 | 5 | In distribution |
| 12595 | Base Plate Max Cut Size – mm 33 | 10 | In distribution |
| 14173 | Base Plate Type Convex | 10 | In distribution |
| 2831 | Base Plate Max Cut Size – mm 35 | 5 | In distribution |
| 12719 | Base Plate Type Convex | 5 | In distribution |
| 14283 | Base Plate Max Cut Size – mm 43 | 5 | In distribution |
| 12376 | Coupling Size Diameter – in 2 3/8 | 30 | In distribution |
| 15879 | Descriptive Bag Size Maxi | 10 | In distribution |
| 13706 | Base Plate Type Convex | 10 | In distribution |
| 13876 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14452 | Base Plate Type Convex Light | 10 | In distribution |
| 14254 | Lumen/Inner Diameter 50 mm | 5 | In distribution |
| 12704 | Coupling Size Diameter – in 1 15/16 | 5 | In distribution |
| 2882 | Base Plate Precut Start Hole Size – mm 10 | 5 | In distribution |
| 14222 | Base Plate Precut Start Hole Size – mm 10 | 10 | In distribution |
| 14277 | Base Plate Type Convex Light | 5 | In distribution |
| 15985 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14224 | Lumen/Inner Diameter 40 mm | 10 | In distribution |
| 2846 | Coupling Size Diameter – in 1 15/16 | 10 | In distribution |
| 13846 | Base Plate Precut Start Hole Size – in 1 3/8 | 10 | In distribution |
| 14261 | Coupling Size Diameter – in 1 9/16 | 5 | In distribution |
| 14307 | 10 | In distribution | |
| 12472 | Base Plate Type Flat | 10 | In distribution |
| 12471 | Base Plate Type Flat | 10 | In distribution |
| 12660 | 10 | In distribution | |
| 14424 | Base Plate Type Convex Light | 10 | In distribution |
| 14432 | Descriptive Bag Size Midi | 10 | In distribution |
| 5575 | Base Plate Max Cut Size – in 2 3/16 | 10 | In distribution |
| 12147 | Base Plate Max Cut Size – mm 65 | 30 | In distribution |
| 1754 | Lumen/Inner Diameter 40 mm | 10 | In distribution |
| 12374 | Coupling Size Diameter – in 1 9/16 | 30 | In distribution |
| 12416 | 10 | In distribution | |
| 12136 | Descriptive Bag Size Midi | 30 | In distribution |
| 12135 | Base Plate Max Cut Size – mm 65 | 30 | In distribution |
| 12818 | Descriptive Bag Size Post op | In distribution | |
| 14249 | Base Plate Type Convex | 5 | In distribution |
| 14243 | Base Plate Precut Start Hole Size – in 9/16 | 5 | In distribution |
| 14414 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14512 | Base Plate Type Convex Light | 10 | In distribution |
| 14276 | Base Plate Precut Start Hole Size – in 1 3/8 | 5 | In distribution |
| 13925 | Lumen/Inner Diameter 50 mm | 10 | In distribution |
| 14451 | Base Plate Precut Start Hole Size – mm 21 | 10 | In distribution |
| 12375 | Descriptive Bag Size Maxi | 30 | In distribution |
| 14250 | Base Plate Precut Start Hole Size – mm 15 | 5 | In distribution |
| 2881 | Lumen/Inner Diameter 40 mm | 5 | In distribution |
| 12992 | Base Plate Type Convex | 10 | In distribution |
| 12596 | Base Plate Max Cut Size – in 1 11/16 | 10 | In distribution |
| 2125 | Base Plate Max Cut Size – mm 35 | 30 | In distribution |
| 15954 | Lumen/Inner Diameter 40 mm | 10 | In distribution |
| 12991 | Base Plate Precut Start Hole Size – mm 15 | 10 | In distribution |
| 2832 | Lumen/Inner Diameter 50 mm | 5 | In distribution |
| 14252 | Coupling Size Diameter – in 1 9/16 | 5 | In distribution |
| 14681 | 10 | In distribution | |
| 2807 | 30 | In distribution | |
| 14246 | Base Plate Max Cut Size – mm 33 | 5 | In distribution |
| 14225 | Coupling Size Diameter – in 1 15/16 | 10 | In distribution |
| 14262 | Coupling Size Diameter – in 1 15/16 | 5 | In distribution |
| 12841 | Coupling Size Diameter – in 1 9/16 | 5 | In distribution |
| 14238 | Lumen/Inner Diameter 60 mm | 5 | In distribution |
| 14454 | Base Plate Precut Start Hole Size – in 1 1/4 | 10 | In distribution |
| 15875 | Base Plate Precut Start Hole Size – mm 30 | 10 | In distribution |
| 12346 | Coupling Size Diameter – in 2 3/8 | 30 | In distribution |
| 2808 | 30 | In distribution | |
| 1759 | Lumen/Inner Diameter 60 mm | 10 | In distribution |
| 12177 | Descriptive Bag Size Maxi | 30 | In distribution |
| 13860 | Base Plate Precut Start Hole Size – in 1/2 | 10 | In distribution |
| 12993 | Base Plate Precut Start Hole Size – mm 21 | 10 | In distribution |
| 14442 | Base Plate Max Cut Size – mm 43 | 10 | In distribution |
| 13870 | Base Plate Precut Start Hole Size – in 1/2 | 10 | In distribution |
| 2836 | Coupling Size Diameter – in 1 15/16 | 5 | In distribution |
| 14404 | Base Plate Precut Start Hole Size – mm 15 | 10 | In distribution |
| 2156 | Descriptive Bag Size Pediatric | 10 | In distribution |
| 14226 | Lumen/Inner Diameter 60 mm | 10 | In distribution |
| 14258 | Base Plate Precut Start Hole Size – mm 45 | 5 | In distribution |
| 14255 | Base Plate Max Cut Size – in 1 3/4 | 5 | In distribution |
| 15982 | Coupling Size Diameter – in 1 15/16 | 10 | In distribution |
| 14271 | Base Plate Type Convex Light | 5 | In distribution |
| 12170 | Base Plate Max Cut Size – mm 75 | 30 | In distribution |
| 2803 | Lumen/Inner Diameter 60 mm | 30 | In distribution |
| 12709 | Base Plate Precut Start Hole Size – in 1 5/8 | 5 | In distribution |
| 15876 | Base Plate Precut Start Hole Size – in 1 3/8 | 10 | In distribution |
| 12701 | Base Plate Precut Start Hole Size – in 9/16 | 5 | In distribution |
| 13621 | Base Plate Type Flat | In distribution | |
| 14416 | Base Plate Precut Start Hole Size – mm 15 | 10 | In distribution |
| 14434 | Base Plate Type Convex Light | 10 | In distribution |
| 12708 | Base Plate Max Cut Size – in 1 11/16 | 5 | In distribution |
| 12419 | 10 | In distribution | |
| 12579 | Lumen/Inner Diameter 60 mm | 10 | In distribution |
| 14412 | Descriptive Bag Size Maxi | 10 | In distribution |
| 14405 | Descriptive Bag Size Midi | 10 | In distribution |
| 2182 | Lumen/Inner Diameter 40 mm | 5 | In distribution |
| 1756 | Descriptive Bag Size Maxi | 10 | In distribution |
| 2801 | Lumen/Inner Diameter 40 mm | 30 | In distribution |
| 14281 | Coupling Size Diameter – in 1 9/16 | 5 | In distribution |
| 8115 | Coupling Size Diameter – in 1 15/16 | 10 | In distribution |
| 12355 | Lumen/Inner Diameter 50 mm | 30 | In distribution |
| 12386 | Coupling Size Diameter – in 2 3/8 | 30 | In distribution |
| 14419 | Base Plate Precut Start Hole Size – in 9/16 | 10 | In distribution |
| 13845 | Base Plate Type Flat | 10 | In distribution |
| 12805 | Base Plate Type Flat | In distribution | |
| 12149 | Descriptive Bag Size Midi | 30 | In distribution |
| 14511 | Base Plate Max Cut Size – mm 33 | 10 | In distribution |
| 13964 | Descriptive Bag Size Midi | 10 | In distribution |
| 15984 | Lumen/Inner Diameter 40 mm | 10 | In distribution |
| 13924 | Lumen/Inner Diameter 40 mm | 10 | In distribution |
| 14717 | Base Plate Precut Start Hole Size – in 9/16 | 10 | In distribution |
| 12130 | Base Plate Precut Start Hole Size – mm 20 | 30 | In distribution |
| 14413 | Base Plate Precut Start Hole Size – mm 15 | 10 | In distribution |
| 12848 | Base Plate Precut Start Hole Size – in 1 3/4 | 5 | In distribution |
| 14257 | Base Plate Precut Start Hole Size – mm 40 | 5 | In distribution |
| 14291 | Base Plate Max Cut Size – mm 43 | 5 | In distribution |
| 14691 | 10 | In distribution | |
| 12529 | Descriptive Bag Size Midi | 10 | In distribution |
| 12620 | 10 | In distribution | |
| 12174 | Descriptive Bag Size Maxi | 30 | In distribution |
| 15956 | Coupling Size Diameter – in 2 3/8 | 10 | In distribution |
| 5570 | Base Plate Max Cut Size – mm 55 | 10 | In distribution |
| 12344 | Coupling Size Diameter – in 1 9/16 | 30 | In distribution |
| 12808 | Base Plate Max Cut Size – mm 70 | In distribution | |
| 12175 | Base Plate Precut Start Hole Size – mm 30 | 30 | In distribution |
| 13986 | Coupling Size Diameter – in 2 3/8 | 10 | In distribution |
| 12706 | Base Plate Precut Start Hole Size – in 1 1/4 | 5 | In distribution |
| 14308 | 10 | In distribution | |
| 12432 | Base Plate Max Cut Size – mm 33 | 10 | In distribution |
| 14106 | Base Plate Max Cut Size – mm 43 | 10 | In distribution |
| 14239 | Base Plate Precut Start Hole Size – in 1 5/8 | 5 | In distribution |
| 14293 | Base Plate Precut Start Hole Size – mm 25 | 5 | In distribution |
| 14422 | Base Plate Type Convex Light | 10 | In distribution |
| 14435 | Base Plate Type Convex Light | 10 | In distribution |
| 14453 | Descriptive Bag Size Midi | 10 | In distribution |
| 15955 | Descriptive Bag Size Midi | 10 | In distribution |
Showing 250 of 252 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| New Image | Hollister Incorporated | 236 |
| SenSura Mio | Coloplast A/S | 200 |
| Premier | Hollister Incorporated | 182 |
| SenSura Mio Convex | Coloplast A/S | 162 |
| SenSura Mio Convex brand logo | Coloplast A/S | 82 |
| SenSura Click | Coloplast A/S | 69 |
| Securi-T | Hollister Incorporated | 59 |
| SenSura Mio Convex Flip | Coloplast A/S | 58 |
| SenSura | Coloplast A/S | 53 |
| Karaya 5 | Hollister Incorporated | 38 |
| Sensura Flex | Coloplast A/S | 37 |
| Brava | Coloplast A/S | 31 |
Showing 12 of 31. All products under Collector, Ostomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K881636 | 1988-07-13 |
| K861070 | 1986-06-16 |
| K844685 | 1985-01-08 |
| K833567 | 1984-05-02 |
| K840267 | 1984-04-02 |
| K840265 | 1984-04-02 |
| K840269 | 1984-04-02 |
| K833571 | 1984-01-30 |
| K833565 | 1984-01-30 |
| K833569 | 1983-12-27 |
| K833566 | 1983-12-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.