Duns Number:628013963
Device Description: GELFOAM® PLUS - COMPRESSED SPONGE is an implantable hemostat supplied as a ready to use me GELFOAM® PLUS - COMPRESSED SPONGE is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Compressed Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device
Catalog Number
1503187
Brand Name
Gelfoam Plus
Version/Model Number
1503187
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LMF
Product Code Name
Agent, absorbable hemostatic, collagen based
Public Device Record Key
0f60c2e7-2745-4e3a-82e7-c8ada9b0f157
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
September 08, 2016
Package DI Number
50085412095153
Quantity per Package
6
Contains DI Package
00085412095158
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |