Medline Industries, Inc.
Drape, Robotic ARM, Sterile, 15X70"
15manufacturers in China registered for this device type
24catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (6), Shanghai (3), Anhui (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Dongguan SafeSecure Plastics Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 6 |
| S.E.S. Healthcare Products Co., Ltd. | Heifei | Anhui | Contract manufacturer | 5 |
| Shanghai Leyi Plastic Products Co Ltd | Shanghai | Shanghai | Contract manufacturer | 5 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Shanghai Huayue Packaging Products Co., Ltd. | Fengxian District | Shanghai | Contract manufacturer | 18 |
Showing 12 of 15. All 15 manufacturers in China registered for Cover, Barrier, Protective
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | MMP |
| Device type | Cover, Barrier, Protective |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Record published | 2022-08-04 |
| Record revised | 2022-06-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 100, case of 80, case of 13, case of 25, case of 3, case of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DNSC39830 | In distribution | |
| 31405CS | In distribution | |
| BOST98668 | In distribution | |
| DNSC26466 | In distribution | |
| DNSC20010 | In distribution | |
| DNSC31753 | In distribution | |
| DNSC15036 | In distribution | |
| DYNJE5930 | In distribution | |
| DNSC37326 | In distribution | |
| DNSC28067 | In distribution | |
| DYNJE4350 | In distribution | |
| DYNJ69992 | In distribution | |
| DNSC25514 | In distribution | |
| DNSCAMDKP18 | In distribution | |
| DNSC31482 | In distribution | |
| DYNDX32032 | In distribution | |
| DNSC28268 | In distribution | |
| DNSC97175 | In distribution | |
| DNSC39821 | In distribution | |
| ENGMICROMD1 | In distribution | |
| DYNJE60020NS | In distribution | |
| 58700 | In distribution | |
| DNSC29436 | In distribution | |
| DNSC26560 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 63 |
| Medline | Medline Industries, Inc. | 27 |
| Patterson® | Patterson Dental Supply, Inc. | 11 |
| Curaplex | Bound Tree Medical, LLC | 9 |
| Equipment Cover Bag Type | Argon Medical Devices, Inc. | 8 |
| Cover, Barrier, Protective | Mavig Gmbh | 7 |
| Pinnacle X-Ray Sensor Sheaths | Metrex Research | 7 |
| Mizuho OSI | Maytex Corp. | 6 |
| Spectrum, Inc. | Spectrum Medical Ltd | 5 |
| Quala | National Distribution & Contracting Inc | 5 |
| Equipment Cover | Argon Medical Devices, Inc. | 5 |
| Equipment Cover Dome Type | Argon Medical Devices, Inc. | 5 |
Showing 12 of 97. All products under Cover, Barrier, Protective
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K032065 | 2003-09-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2023-05-15 | Class II | Nonconforming Material/Component | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | 1,231,480 kits |
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.