Duns Number:083171244
Device Description: ORAMEM 15x20OraMem absorbable collagen membrane is a white, compressed, non-friable matrix ORAMEM 15x20OraMem absorbable collagen membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon. The OraMem membrane is completely absorbable, eliminating the need for the second surgical procedure often required to remove a non-resorbabble membrane. The collage is currently used for general and dental surgery as absorbable hemostatic agents and absorbable wound dressings.
Catalog Number
#ORAMEM15X20
Brand Name
Salvin OraMEM™ Absorbable Collagen Membrane
Version/Model Number
#ORAMEM15X20
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
-
Product Code
LYC
Product Code Name
Bone grafting material, synthetic
Public Device Record Key
129a9b77-b38c-49a9-9cb0-11803269511d
Public Version Date
April 07, 2021
Public Version Number
8
DI Record Publish Date
September 22, 2015
Package DI Number
30381780072571
Quantity per Package
12
Contains DI Package
10381780072577
Package Discontinue Date
March 31, 2020
Package Status
Not 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 | 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 |