Patterson®
Barrier Protection Head Rest Cover
15manufacturers in China registered for this device type
11catalogue numbers in this listing
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 | Patterson Dental Supply, Inc., United States |
|---|---|
| FDA product code | MMP |
| Device type | Cover, Barrier, Protective |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K962288 |
| Record published | 2016-09-23 |
| Record revised | 2024-12-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 70850750 | 1,200 | In distribution | |
| 70850586 | 500 | In distribution | |
| 070851808 | 250 | In distribution | |
| 70850503 | 225 | In distribution | |
| 070851840 | 250 | In distribution | |
| 70850693 | 500 | In distribution | |
| 070850768 | 1,200 | In distribution | |
| 70850545 | 500 | In distribution | |
| 70850669 | 500 | In distribution | |
| 70850644 | 500 | In distribution | |
| 70850800 | 250 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 63 |
| Medline | Medline Industries, Inc. | 27 |
| Medline Industries, Inc. | Medline Industries, Inc. | 24 |
| 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
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Kerr Corporation | 510(k) number | 2015-02-11 | Class II | Packaging | Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing | 172 | 2015-05-21 |
| Penner Patient Care, Inc | 510(k) number | 2015-01-30 | Class II | Use error | If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tipping and injury to the operator or patient could result. The device manual was updated with an additional warning statement. | 158 | 2016-03-10 |
| Metrex Research | 510(k) number | 2011-09-20 | Class II | Error in labeling | The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500). | 3,348 units | 2012-11-29 |
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.