Duns Number:008124539
Device Description: 3% Bismuth Tribromophenate in a petrolatum blendMed-High AbsorbencyFor wound stages 2,3,4
Catalog Number
-
Brand Name
Xeroform Petrolatum Dressings
Version/Model Number
3042
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
K152970,K152970,K152970
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
ef85b13d-74d0-442e-82d2-7604f75709c4
Public Version Date
September 14, 2022
Public Version Number
1
DI Record Publish Date
September 06, 2022
Package DI Number
00840117324237
Quantity per Package
12
Contains DI Package
00840117324244
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |