Duns Number:216344051
Device Description: Zinc Paste Bandage
Catalog Number
4956
Brand Name
VISCOPASTE PB7 3""X10YD CTN 12
Version/Model Number
4956
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K863930,K863930,K863930
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
f779ce11-7911-44ee-920d-e4828bd51518
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
May 15, 2020
Package DI Number
05000223415044
Quantity per Package
12
Contains DI Package
05000223415457
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |