Duns Number:618054084
Device Description: Absorbable Hemostatic Sponge, Collagen Based
Catalog Number
-
Brand Name
Gelfoam
Version/Model Number
Size 4, 2 sponges per envelope
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286
Product Code
LMF
Product Code Name
Agent, absorbable hemostatic, collagen based
Public Device Record Key
7f5bed05-7c19-4044-81b6-ce1fbe5a2fb7
Public Version Date
December 17, 2020
Public Version Number
6
DI Record Publish Date
September 01, 2014
Package DI Number
00300090396053
Quantity per Package
6
Contains DI Package
10300090396050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |
| 3 | A medical device with high risk that requires premarket approval | 11 |