Duns Number:167102750
Device Description: Cranberry Inspire Nitrile Exam Powder Free Gloves , Sample Pack
Catalog Number
-
Brand Name
Cranberry
Version/Model Number
CR3380_SP
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
7d6406bf-c874-4411-a0a5-4b5c5ea6d49c
Public Version Date
June 16, 2022
Public Version Number
2
DI Record Publish Date
May 24, 2022
Package DI Number
20817508023721
Quantity per Package
100
Contains DI Package
10817508023724
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 | 8 |