Duns Number:023904428
Device Description: Gauze Bandage Roll STERILE 6-PLY 100% COTTON 3.4" x 3.6 Yards
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-4263
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
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
cc18a218-612b-4778-afef-0691f26b5fcf
Public Version Date
September 29, 2022
Public Version Number
3
DI Record Publish Date
October 05, 2018
Package DI Number
00612479126909
Quantity per Package
96
Contains DI Package
00612479126893
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 |