Duns Number:083171244
Device Description: ORAFOAM Absorbable Collagen Hemostatic Sponge 1/2" x 1"
Catalog Number
ORAFOAM-PKG-18
Brand Name
OraFOAM™
Version/Model Number
ORAFOAM-PKG-18
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"
Yes
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
P850010,P850010
Product Code
LMF
Product Code Name
Agent, absorbable hemostatic, collagen based
Public Device Record Key
ffa76314-2151-4a89-8c27-bf23a181b7cc
Public Version Date
October 25, 2022
Public Version Number
4
DI Record Publish Date
February 04, 2019
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |