FDA Registration Active 🇺🇸 United States

Gentell Collagen Wound Dressing; Particles, 2"x2" and 4"x5.25"

Reg #: 2530957 · FEI: 1000522686 · Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1

Registration Details

Registration Name
GENTELL
Registration Number
2530957
FEI Number
1000522686
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
180 Rittenhouse Circle
City
Bristol
State
PA
ZIP
19007
Country
US

Regulatory Submissions

510(k) Number
K122325

Owner / Operator

Firm Name
GENTELL
Operator Number
10026501
Address
180 Rittenhouse Circle,
City
Bristol
State
PA
Postal Code
19007
Country
US
Correspondent
Michael Alford

Products

Device Name Product Code
Wound Dressing With Animal-Derived Material(S) KGN

Proprietary Names

Gentell Collagen Wound Dressing; Particles, 2"x2" and 4"x5.25" Gentell Collagen Wound Dressing: 4"x4", 7"x7"

Establishment Types

Repack or Relabel Medical Device