FDA Registration
Active
🇨🇳 China
DUP9340 Gazetex 100% Cotton , 6-ply, Fluff Sponge 6" x 6I-3/4" Sterile
Reg #: 3003636207
·
FEI: 3003636207
·
Expires 2025
Products
1
Proprietary Names
24
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DERMA SCIENCES NANTONG INCORPORATION
- Registration Number
- 3003636207
- FEI Number
- 3003636207
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO. 24 TONGZHOU ROAD, NANTONG, ECONOMIC AND TECHNOLOGICAL
- City
- DEVELOPMENT Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K946326
Owner / Operator
- Firm Name
- GENTELL
- Operator Number
- 10026501
- Address
- 180 Rittenhouse Circle,
- City
- Bristol
- State
- PA
- Postal Code
- 19007
- Country
- US
- Correspondent
- Michael Alford
US Agent
- Business Name
- Gentell
- Contact Name
- Michael Alford
- Address
- 1000 Floral Vale Blvd Ste 400
- City
- Yardley
- State
- PA
- ZIP
- 19067
- Country
- US
- [email protected]
- Phone
- 800 8409041 ext. 302
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2022-10-28 |
Proprietary Names
DUP9340 Gazetex 100% Cotton , 6-ply, Fluff Sponge 6" x 6I-3/4" Sterile
DUP9333 Gazetex 100% Cotton , 6-ply, Fluff Sponge 6" x 6-3/4" Non -Sterile
DUP77784 Dutex 100% Cotton 2 ply conforming Bandage 6" x 4.1 yd Sterile
DUP75203 Duform Synthetic Conforming Bandage 3" x 4.1 yd Sterile
DUP9320-48 Gazetex Bandage Rolls 4-1/2" x 4.1 yds, 6 ply Non-Sterile
DUP77782 Dutex 100% Cotton 2 ply conforming Bandage 3" x 4.1 yd Sterile
DUP77781 Dutex 100% Cotton 2 ply conforming Bandage 2" x 4.1 yd Sterile
DUP75204 Duform Synthetic Conforming Bandage 4" x 4.1 yd Sterile
DUP75206 Duform Synthetic Conforming Bandage 6" x 4.1 yd Sterile
DUP9345 Gazetex 100% Cotton , 6-ply, Fluff Sponge 7-3/4" x 8-3/4" Sterile
DUP76782 Dutex 100% Cotton 2 ply conforming Bandage 3" x 4.1 yd Non-Sterile
DUP76781 Dutex 100% Cotton 2 ply conforming Bandage 2" x 4.1 yd Non-Sterile
DUP76783 Dutex 100% Cotton 2 ply conforming Bandage 4" x 4.1 yd Non-Sterile
DUP75106 Duform Synthetic Conforming Bandage 6" x 4.1 yd Non-Sterile
DUP76784 Dutex 100% Cotton 2 ply conforming Bandage 6" x 4.1 yd Non-Sterile
DUP77783 Dutex 100% Cotton 2 ply conforming Bandage 4" x 4.1 yd Sterile
DUP9334 Gazetex 100% Cotton , 6-ply, Fluff Sponge 7-3/4" x 8-3/4" Non- Sterile
DUP9322 Gazetex Bandage Rolls 4-1/2" x 4.1 yds, 6 ply Sterile
DUP75202 Duform Synthetic Conforming Bandage 2" x 4.1 yd Sterile
DUP75103 Duform Synthetic Conforming Bandage 3" x 4.1 yd Non-Sterile
DUP75104 Duform Synthetic Conforming Bandage 4" x 4.1 yd Non-Sterile
DUP9321 Gazetex Bandage Rolls 2-1/2" x 3 yds, 6 ply Sterile
DUP75102 Duform Synthetic Conforming Bandage 2" x 4.1 yd Non-Sterile
DUP9320 Gazetex Bandage Rolls 4-1/2" x 4.1 yds, 6 ply Non-Sterile
Establishment Types
Manufacture Medical Device