ACE
Sani Sleeve 2X60" Ster 10/PKG L/F
15manufacturers in China registered for this device type
1catalogue number
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 | Ace Surgical Supply Co., Inc., United States |
|---|---|
| FDA product code | MMP |
| Device type | Cover, Barrier, Protective |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Premarket notification | Exempt |
| Record published | 2015-10-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Tyvec bag of 10 |
| Sizes | Length 60 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6411000 | Length 60 in | 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 |
| 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 |
Showing 12 of 97. All products under Cover, Barrier, Protective
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.