Duns Number:618054084
Device Description: Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Sponge USP and T Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Sponge USP and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI®, 5,000 International Units)
Catalog Number
-
Brand Name
GELFOAM-JMI™ Sponge Kit
Version/Model Number
Size 100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
Product Code
LMF
Product Code Name
Agent, absorbable hemostatic, collagen based
Public Device Record Key
82696ab3-3151-43b2-b0b1-c2515bd2bb9a
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
June 05, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |