Duns Number:199692794
Device Description: ProGear™ Isolation Mask, Earloop, Yellow (USA)
Catalog Number
-
Brand Name
ProGear
Version/Model Number
FM81010
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
943835fc-9270-49f3-b353-d6abfa64d630
Public Version Date
May 06, 2020
Public Version Number
3
DI Record Publish Date
October 27, 2016
Package DI Number
20852212003010
Quantity per Package
10
Contains DI Package
00852212003016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case