Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
8884433205
Brand Name
Vaseline
Version/Model Number
8884433205
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)
-
Over the Counter (OTC)
Yes
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
17e1040c-83de-46e8-8ec8-5519d806ea57
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
August 19, 2019
Package DI Number
30884521135769
Quantity per Package
4
Contains DI Package
20884521135762
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |