Premier Value
Sterile Wound Closure Strips- 1/4"x4"
14manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (5), Guangdong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Qidong Farjoy Medical Material Co., Ltd. | Qidong | Jiangsu | Contract manufacturer | 8 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| Rfx+care Manufacturing Co., Ltd. | Shaoxing | Zhejiang | Repacker / relabeller | 21 |
| Jiangsu Qiantai Medical Instrument Co., Ltd. | Tai Zhou | Jiangsu | Contract manufacturer | 16 |
| HongYu BioTech (ShenZhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 15 |
| Yafho BIO-Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 14 |
| Zhejiang Hangbiao Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 9 |
| Nantong MedTech Medical Products Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Strip, Adhesive, Closure, Skin
Record
| Listed by | Pharmacy Value Alliance, LLC |
|---|---|
| FDA product code | FPX |
| Device type | Strip, Adhesive, Closure, Skin |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5240 |
| 510(k) | K931005 |
| Record published | 2022-06-21 |
| Record revised | 2024-05-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 24 |
| Distribution end date | 2024-05-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 84098602155 | 30 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterion® Skin Closure | Aspen Surgical Products, Inc. | 53 |
| Aspen® Skin Closure | Aspen Surgical Products, Inc. | 8 |
| Suture Strip® | Derma Sciences Canada, Inc. | 7 |
| ACE | Ace Surgical Supply Co., Inc. | 7 |
| Curad | Medline Industries, Inc. | 6 |
| Henry Schein | Henry Schein, Inc. | 6 |
| Dukal | Dukal LLC | 6 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Shur-Strip® | Derma Sciences Canada, Inc. | 4 |
| CareOne | Ahold U.S.A., Inc. | 1 |
| Walgreens | Walgreen Co. | 1 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 1 |
Showing 12 of 18. All products under Strip, Adhesive, Closure, Skin
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.