Duns Number:080935429
Device Description: Occlusive Gauze Strip Overwrap,3% Bismuth Tribromophenate in Petrolatum Blend
Catalog Number
8884431605
Brand Name
Xeroform
Version/Model Number
8884431605
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
8a47b43b-cfe4-4233-b854-b6dd85ba3473
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
June 27, 2018
Package DI Number
20884527014900
Quantity per Package
50
Contains DI Package
10884527014903
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |