Duns Number:200564891
Device Description: Petrolatum Dressing. Fine Mesh Gauze Impregnated with 3% Bismuth Tribromophenate in a Pet Petrolatum Dressing. Fine Mesh Gauze Impregnated with 3% Bismuth Tribromophenate in a Petrolatum Blend.
Catalog Number
DKC71165
Brand Name
XEROFORM PETROLATUM
Version/Model Number
71165
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"
Yes
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
K921289,K921289
Product Code
GER
Product Code Name
GAUZE, EXTERNAL (WITH DRUG/BIOLOGIC/ANIMAL SOURCE MATERIAL)
Public Device Record Key
e4e5a299-c83e-4d11-a0da-c85e4c64d125
Public Version Date
October 15, 2018
Public Version Number
1
DI Record Publish Date
September 13, 2018
Package DI Number
30381780471336
Quantity per Package
6
Contains DI Package
10381780471332
Package Discontinue Date
-
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 | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 42 |