Duns Number:101926900
Device Description: Dermatec Bronze Star latex PF exam glove xlarge 100/box, 10 box/case
Catalog Number
GL603PFB
Brand Name
Dermatec Bronze Star
Version/Model Number
GL603PFB
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)
Yes
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
b6ffef21-c4b6-4ad7-8271-f8606c32b3ec
Public Version Date
September 13, 2022
Public Version Number
1
DI Record Publish Date
September 05, 2022
Package DI Number
10813417020212
Quantity per Package
10
Contains DI Package
00813417020215
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box