Duns Number:089569581
Device Description: PrimaPro GentleWare ASTM Level 2 Face Mask, White, 3 Ply with Ear Loops, Latex Free, 50 Ma PrimaPro GentleWare ASTM Level 2 Face Mask, White, 3 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
Catalog Number
-
Brand Name
PrimaPro
Version/Model Number
W182028EL-BX
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"
-
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
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
8cdc35b0-c151-454a-91b2-8f0bbccc7b77
Public Version Date
December 31, 2020
Public Version Number
2
DI Record Publish Date
September 18, 2020
Package DI Number
10850022371476
Quantity per Package
10
Contains DI Package
00850022371479
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case