Pilling
Keyhole Bracket, hole opening 19mm (.750"), silicone, height 38.1mm (1.5"), OL 39.37mm (1.55")
5manufacturers in China registered for this device type
79catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
| AR Medicom Inc., (Asia), Ltd. | Hongkong | Hong Kong | Exporter | 5 |
| Wipak Packaging (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2017-05-03 |
| Record revised | 2023-11-22 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 0.5 to 26 in; width 1 to 27 in; height 1 to 8 in; width 3 to 25 mm |
| Distribution end date | 2023-11-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P37593 | In distribution | |
| P37380 | In distribution | |
| P37326 | Height 2.5 in | Withdrawn |
| P37379 | Length 1.5 in | Withdrawn |
| P37390 | Width 1.5 in | Withdrawn |
| P37321 | Width 10.5 in | Withdrawn |
| P32632 | Length 19.75 in | Withdrawn |
| P37309 | Width 9 in | Withdrawn |
| P88097 | Length 23 in | Withdrawn |
| P37345 | Length 1.5 in | Withdrawn |
| P37333 | Length 11 in | Withdrawn |
| P37338 | Length 10.5 in | Withdrawn |
| P37339 | Width 7.5 in | Withdrawn |
| P37545 | Width 9.25 in | Withdrawn |
| P37324 | Length 10.5 in | Withdrawn |
| P37325 | Height 2.5 in | Withdrawn |
| P37383 | Width 1 in | Withdrawn |
| P37305 | Height 1 in | Withdrawn |
| P37378 | Width 1.5 in | Withdrawn |
| P37329 | Width 9.5 in | Withdrawn |
| P37306 | Width 10 in | Withdrawn |
| P37331 | Length 11 in | Withdrawn |
| P37328 | Length 9 in | Withdrawn |
| P37344 | Width 1.5 in | Withdrawn |
| P37352 | Width 1.5 in | Withdrawn |
| P37357 | Width 1 in | Withdrawn |
| P37397 | Width 9.5 in | Withdrawn |
| P37349 | Width 1 in | Withdrawn |
| P37312 | Length 4 in | Withdrawn |
| P37358 | Width 5 in | Withdrawn |
| P37337 | Width 10.5 in | Withdrawn |
| P37318 | Length 3.5 in | Withdrawn |
| P37353 | Width 1.5 in | Withdrawn |
| P37316 | Height 8 in | Withdrawn |
| P37336 | Width 5 in | Withdrawn |
| P37332 | Height 5 in | Withdrawn |
| P37374 | Width 1.5 in | Withdrawn |
| P37355 | Width 6 mm | Withdrawn |
| P37314 | Length 4 in | Withdrawn |
| P37327 | Width 13 in | Withdrawn |
| P37382 | Width 25 mm | Withdrawn |
| P37433 | Width 1 in | Withdrawn |
| P37373 | Width 4 mm | Withdrawn |
| P37319 | Withdrawn | |
| P37341 | Width 9.25 in | Withdrawn |
| P37372 | Length 1.5 in | Withdrawn |
| P37308 | Width 10 in | Withdrawn |
| P37376 | Width 10 mm | Withdrawn |
| P37395 | Length 14.13 in | Withdrawn |
| P88044 | Length 23 in | Withdrawn |
| P37454 | Width 4.25 in | Withdrawn |
| P37387 | Width 1 in | Withdrawn |
| P37310 | Height 2.5 in | Withdrawn |
| P37544 | Length 7.5 in | Withdrawn |
| P37313 | Width 20 in | Withdrawn |
| P37485 | Width 5 mm | Withdrawn |
| P37311 | Length 3 in | Withdrawn |
| P37315 | Height 2.5 in | Withdrawn |
| P37317 | Height 8 in | Withdrawn |
| P37396 | Width 9.63 in | Withdrawn |
| P37335 | Length 9 in | Withdrawn |
| P37437 | Width 1.5 in | Withdrawn |
| P37330 | Length 19.5 in | Withdrawn |
| P37398 | Width 18 in | Withdrawn |
| P37334 | Length 5 in | Withdrawn |
| P37320 | Length 10.5 in | Withdrawn |
| P37404 | Length 18.25 in | Withdrawn |
| P37564 | Length 0.5 in | Withdrawn |
| P37322 | Height 1.5 in | Withdrawn |
| P37432 | Width 1 in | Withdrawn |
| P53659 | Length 1.5 in | Withdrawn |
| P37304 | Height 2.5 in | Withdrawn |
| P37351 | Width 1.5 in | Withdrawn |
| P88044 | Withdrawn | |
| P37384 | Width 1 in | Withdrawn |
| P37419 | Width 10.5 in | Withdrawn |
| P37872 | Length 10 in | Withdrawn |
| P37356 | Width 1 in | Withdrawn |
| P37323 | Height 2.5 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrusafe | Summit Medical LLC | 6,357 |
| V. Mueller | Steris Corporation | 1,080 |
| Ermis | Ermis MedTech | 597 |
| Bahadir USA | Bahadir USA LLC | 561 |
| Avalign | Avalign Technologies, Inc. | 447 |
| Sklar® | Sklar Corporation | 363 |
| HNM Medical | HNM Stainless, LLC. | 337 |
| Surgical Instrument | SIN Sistema DE Implante Nacional S.A | 295 |
| ReLine | Nuvasive, Inc. | 290 |
| Case Medical | Case Medical, Inc. | 289 |
| Millennium | Avalign Technologies, Inc. | 268 |
| V. Mueller | Carefusion 2200, Inc. | 174 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193066 | 2020-08-06 |
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.