Medical Grade Adhesive Tapes 10×5 Cm for Fixing Sheaths and Drapes
Catalogue number 12.U0014.00, listed by Omnia Medical, United States, under Drape, Adhesive, Aerosol. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Hubei (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Classic NEW-Type Medical Products Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 13 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. | Siyang | Jiangsu | Manufacturer | 21 |
| Guangzhou Fuzelong Hygiene Material Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 17 |
| Wuhan Huawei Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 16 |
| Yafho BIO-Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 14 |
| Ningbo Hysent Medical Technology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 13 |
| Hubei Hendry Medical Appliance Co., Ltd. | Xiaogan | Hubei | Manufacturer | 12 |
| Wuhan Hangu Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 11 |
| Hony Medical Co., Ltd. | Taishan | Guangdong | Contract manufacturer | 10 |
Record
| Listed by | Omnia Medical, United States |
|---|---|
| FDA product code | KGT |
| Device type | Drape, Adhesive, Aerosol |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4380 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-28 |
| Record revised | 2024-09-11 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 12.U0014.00 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Adhesive Films | Omnia Medical | 2 |
| 3M™ Steri-Drape™ | 3M Company | 1 |
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.