Duns Number:080935429
Device Description: Cotton Undercast Padding,Regular Finish
Catalog Number
1418
Brand Name
Webril
Version/Model Number
1418
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
ITG
Product Code Name
BANDAGE, CAST
Public Device Record Key
18559f52-60a4-4b39-b768-49638f81f5ee
Public Version Date
September 03, 2020
Public Version Number
3
DI Record Publish Date
June 22, 2018
Package DI Number
20884527015204
Quantity per Package
72
Contains DI Package
10884527015207
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 |