Sterion®Clamp Cover Fabric
Provides a sterile interface between the operating room surgical lamps (non-sterile) and the Surgeon or Nurse (sterile).
45manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (12), Zhejiang (11), Shanghai (7). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Nantong City Yojo Medical Products Co., Ltd. | Haimen | Jiangsu | Contract manufacturer | 14 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Anhui Medfaith Medical Devices Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 6 |
| Shanghai Kohope Medical Devices Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
Showing 12 of 45. All 45 manufacturers in China registered for Instrument, Surgical, Disposable
Record
| Listed by | Aspen Surgical Products, Inc., United States |
|---|---|
| FDA product code | KDC |
| Device type | Instrument, Surgical, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-25 |
| Record revised | 2022-11-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 10, pack of 100, pack of 40, pack of 20 |
| Distribution end date | 2022-04-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 061011PBX | In distribution | ||
| 061012PBX | In distribution | ||
| 071001BBG | In distribution | ||
| 062013BBG | In distribution | ||
| 072002BBG | In distribution | ||
| 071002BBG | In distribution | ||
| 072002PBX | In distribution | ||
| 062012BBG | In distribution | ||
| 062011BBG | In distribution | ||
| 071001PBX | In distribution | ||
| 071002PBX | In distribution | ||
| 072004PBX | In distribution | ||
| 072001PBX | In distribution | ||
| 072004BBG | In distribution | ||
| 061013PBX | In distribution | ||
| 072004PBX | 4 | Withdrawn | |
| 061013PBX | 2 | Withdrawn | |
| 071002PBX | 4 | Withdrawn | |
| 071001BBG | 100 | Withdrawn | |
| 071002BBG | 100 | Withdrawn | |
| 072001BBG | 100 | Withdrawn | |
| 062012BBG | 20 | Withdrawn | |
| 072002PBX | 4 | Withdrawn | |
| 072004BBG | 100 | Withdrawn | |
| 072001PBX | 4 | Withdrawn | |
| 071001PBX | 4 | Withdrawn | |
| 072002BBG | 100 | Withdrawn | |
| 061011PBX | 2 | Withdrawn | |
| 062011BBG | 20 | Withdrawn | |
| 062013BBG | 20 | Withdrawn | |
| 061012PBX | 2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 213 |
| DeRoyal | Deroyal Industries, Inc. | 167 |
| Medical Action Industries | Medical Action Industries, Inc. | 112 |
| Centurion | Centurion Medical Products Corporation | 98 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 77 |
| Sterion® Vessel Loop | Aspen Surgical Products, Inc. | 47 |
| Integra | Provision | 26 |
| Devon | Cardinal Health | 25 |
| Instrument, Surgical, Disposable | Summit Medical LLC | 23 |
| Dermapac, Inc. | Dermapac Inc. | 22 |
| CareFusion 2200 | Provision | 20 |
| Medline | Medline Industries, Inc. | 20 |
Showing 12 of 155. All products under Instrument, Surgical, Disposable
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.