Duns Number:962858049
Device Description: HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 8x8 inche HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 8x8 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
Catalog Number
HC8x8
Brand Name
HELICOLL
Version/Model Number
HC8x8
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
K040314,K040314
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
7a7ab2f2-7fcf-4cf8-abf2-1848a80e777b
Public Version Date
July 20, 2020
Public Version Number
1
DI Record Publish Date
July 11, 2020
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 | 5 |