FDA Registration Active 🇨🇳 China

DKC77042 Shur Oil Emulsion Non-Adhering Dressing Size 3" x 8"

Reg #: 3003636207 · FEI: 3003636207 · Expires 2025
Products
1
Proprietary Names
6
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
K921290

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
Phone
800 8409041 ext. 302

Products

Device Name Product Code
Dressing, Wound, Drug FRO

Proprietary Names

DKC77042 Shur Oil Emulsion Non-Adhering Dressing Size 3" x 8" DKC77044 Shur Oil Emulsion Non-Adhering Dressing Size 3" x 8", 3's DKC77041 Shur Oil Emulsion Non-Adhering Dressing Size 3" x 3" DKC77043 Shur Oil Emulsion Non-Adhering Dressing Size 3" x 16" BSK-SPC0003701AB- BLUESKY OIL EMULSION NON-ADH GAUZE 3"X 3" BSK-SPC0003702AB-BLUESKY OIL EMULSION NON-ADH GAUZE 3"X 8"

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)