Duns Number:023904428
Device Description: Collagen Dressings ADVANCED WOUND DRESSING STERILE 4 in x 4 in
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-1852
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
K060804,K060804,K060804
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
3aa49991-3939-4db2-bd67-28a5f14e1f1b
Public Version Date
August 16, 2021
Public Version Number
3
DI Record Publish Date
June 10, 2020
Package DI Number
40612479217254
Quantity per Package
10
Contains DI Package
20612479217243
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |