Duns Number:007941230
Device Description: Mask Surgical Face PRIMAGARD80 Tie Soft Bill Green Large Not Made With Natural Rubber Late Mask Surgical Face PRIMAGARD80 Tie Soft Bill Green Large Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
PG4-2161
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"
Yes
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
ea69ce1c-ac32-4253-9042-f599c47f61b3
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
August 20, 2016
Package DI Number
50885632135857
Quantity per Package
6
Contains DI Package
10885632135859
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |