Duns Number:083171244
Device Description: #ORAMEM SUS 15x20OraMem Sustained absorbable collagen membrane is an absorbable, implanta #ORAMEM SUS 15x20OraMem Sustained absorbable collagen membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.OraMem Sustained absorbable collagen membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achillies) tendon. Bovine tendon is known to be one of the purest sources of Type I collagen that can be readily obtained and processed in commercial amounts. The OraMem Sustained membrane is completely absorbable, eliminating the need for the second surgical procedure required to remove a non-resorbable membrane. The collagen is currently used for general and dental surgery as absorbable hemostatic agents and absorbable wound dressings.
Catalog Number
#ORAMEMSUS15X20
Brand Name
Salvin OraMem®
Version/Model Number
#ORAMEMSUS15X20
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
K992216,K992216
Product Code
LYC
Product Code Name
Bone grafting material, synthetic
Public Device Record Key
f44cd0ea-8bf7-4604-a812-24bac48737d2
Public Version Date
April 07, 2021
Public Version Number
7
DI Record Publish Date
September 22, 2015
Package DI Number
30381780072601
Quantity per Package
12
Contains DI Package
10381780072607
Package Discontinue Date
March 31, 2020
Package Status
Not in Commercial Distribution
Package Type
CAS
| 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 |