Duns Number:083171244
Device Description: HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendon. These collagen products provide wound stabilization and create space during guided tissue regeneration procedures where a longer absorption rate is desired. HeliMEND Advanced collagen membrane is absorbed within 18 weeks.
Catalog Number
62207
Brand Name
HeliMend® Advanced
Version/Model Number
62207
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
K992216,K992216
Product Code
LYC
Product Code Name
Bone grafting material, synthetic
Public Device Record Key
5f708a92-a333-4592-9658-3586f11e777e
Public Version Date
April 07, 2021
Public Version Number
7
DI Record Publish Date
September 22, 2015
Package DI Number
30381780038522
Quantity per Package
12
Contains DI Package
10381780038528
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 |