Duns Number:062312574
Device Description: TUBULAR GAUZE
Catalog Number
-
Brand Name
CVS HEALTH
Version/Model Number
310271_400803
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
15ac38e0-85b4-4a60-b673-c6e03b6ed520
Public Version Date
August 06, 2020
Public Version Number
1
DI Record Publish Date
July 29, 2020
Package DI Number
20050428407947
Quantity per Package
12
Contains DI Package
00050428407943
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 82 |
2 | A medical device with a moderate to high risk that requires special controls. | 139 |
U | Unclassified | 23 |