Duns Number:167102750
Device Description: Cranberry Sigma Latex Exam Powder Free Gloves 100 /BX , XL
Catalog Number
-
Brand Name
Cranberry
Version/Model Number
CR5819
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
LYY
Product Code Name
Latex Patient Examination Glove
Public Device Record Key
81b54e93-1193-4b19-ae66-090fef7c5869
Public Version Date
June 23, 2022
Public Version Number
4
DI Record Publish Date
December 15, 2021
Package DI Number
20817508021802
Quantity per Package
10
Contains DI Package
10817508021805
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 |