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/Bag, 20 Bags/Case, 1,000 Masks/Case, Single Use
Catalog Number
-
Brand Name
PrimaPro
Version/Model Number
W182028EL-BG
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
cb9bdf77-9237-42ea-8974-419003100446
Public Version Date
May 27, 2021
Public Version Number
3
DI Record Publish Date
September 18, 2020
Package DI Number
10850022371483
Quantity per Package
10
Contains DI Package
00850022371486
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case