Duns Number:006922009
Device Description: PUB VINYL MED EXAM GLOVES
Catalog Number
121308
Brand Name
Publix
Version/Model Number
121308
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
LYZ
Product Code Name
Vinyl Patient Examination Glove
Public Device Record Key
7dbe104c-6058-4b72-a82b-d868458fd656
Public Version Date
December 07, 2020
Public Version Number
2
DI Record Publish Date
October 14, 2019
Package DI Number
10041415027746
Quantity per Package
20
Contains DI Package
00041415027749
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 | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 17 |