Duns Number:023904428
Device Description: DRESSING, ANTIMICRO SLVR CALC
Catalog Number
-
Brand Name
McKesson
Version/Model Number
61-88582
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
K080497,K080497,K080497
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
bc1312c5-56b7-424e-bda8-cf8b572e33c1
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
June 10, 2020
Package DI Number
40612479183313
Quantity per Package
48
Contains DI Package
20612479183302
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 |