Duns Number:815240958
Device Description: Extended Cuff Nitrile Examination Glove, Powder-Free, Textured Fingertips, Chemotherapy Dr Extended Cuff Nitrile Examination Glove, Powder-Free, Textured Fingertips, Chemotherapy Drug Tested, Extended Cuff, Blue, X-Small
Catalog Number
-
Brand Name
VIVIT
Version/Model Number
25911
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
552f04af-3d7d-46c9-9c2c-e63fb011686c
Public Version Date
November 08, 2021
Public Version Number
1
DI Record Publish Date
October 30, 2021
Package DI Number
20810084210240
Quantity per Package
10
Contains DI Package
10810084210243
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case