Duns Number:083171244
Device Description: BIOMEND EXTEND 30MM X 40MM (0142) BioMend Extend Absorbable Collagen Membrane is an absorb BIOMEND EXTEND 30MM X 40MM (0142) BioMend Extend Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue generation procedures in periodontal defects to enhance regeneration of periodontal apparatus. The BioMend Extend membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon.
Catalog Number
0142
Brand Name
BioMend® Extend™ Absorbable Collagen Membrane
Version/Model Number
0142
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
K992216,K992216
Product Code
LYC
Product Code Name
Bone grafting material, synthetic
Public Device Record Key
0e0b6c0b-a180-4b1d-98d3-ed46506d42b7
Public Version Date
September 22, 2020
Public Version Number
5
DI Record Publish Date
September 22, 2015
Package DI Number
30381780070782
Quantity per Package
12
Contains DI Package
10381780070788
Package Discontinue Date
-
Package Status
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 |