Duns Number:080935429
Device Description: Cotton Undercast Padding Regular Finish
Catalog Number
3175
Brand Name
Webril
Version/Model Number
3175
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2023
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)
Yes
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
34e3ee25-5982-46e2-8b61-9dd955b23964
Public Version Date
September 03, 2020
Public Version Number
3
DI Record Publish Date
June 23, 2018
Package DI Number
20884521528601
Quantity per Package
72
Contains DI Package
10884521528604
Package Discontinue Date
July 01, 2023
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 | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |