Duns Number:083171244
Device Description: HeliCote ® ABSORBABLE COLLAGEN Wound Dressing, 3/4in x 1 1/2in
Catalog Number
62-201
Brand Name
HeliCote®
Version/Model Number
62-201
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
-
Product Code
LPG
Product Code Name
Material, Dressing, Surgical, Polylactic Acid
Public Device Record Key
e702f0b3-76e8-4b5e-a4a0-996260c068a3
Public Version Date
April 19, 2021
Public Version Number
8
DI Record Publish Date
September 11, 2014
Package DI Number
30381780000291
Quantity per Package
4
Contains DI Package
10381780000297
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |