Duns Number:080171627
Device Description: Powder-Free Latex Examination Gloves
Catalog Number
-
Brand Name
Rampage
Version/Model Number
RPA500L
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
bf5d22ff-4507-4700-9fcb-bca07772e442
Public Version Date
August 08, 2022
Public Version Number
1
DI Record Publish Date
July 29, 2022
Package DI Number
00811114031046
Quantity per Package
10
Contains DI Package
00811114031008
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Carton