Duns Number:657266016
Device Description: HealiAid collagen wound dressing is fabricated by native fibrous, absorbable type I collag HealiAid collagen wound dressing is fabricated by native fibrous, absorbable type I collagen, purified from bovine Achilles tendons. HealiAid can greatly enchance and accelerate tissue ingrowth and support bone augmentation. SA152005 size: 15mm x 20mm x 5mm
Catalog Number
SA152005
Brand Name
HealiAid
Version/Model Number
SA152005
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
54044159-1dfd-4a0b-b055-074341b1ed59
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
July 23, 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 |
|---|---|---|
| U | Unclassified | 3 |