Duns Number:555240671
Device Description: 4 Ply - Medical/ surgical face maskNon- sterile, single useColor white50 masks pack in one 4 Ply - Medical/ surgical face maskNon- sterile, single useColor white50 masks pack in one box
Catalog Number
-
Brand Name
Perfetta Ultra Face Mask
Version/Model Number
White, 50pcs
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
MSH
Product Code Name
Respirator, Surgical
Public Device Record Key
2a07b382-6706-48c1-891e-9d3458659d9d
Public Version Date
November 13, 2020
Public Version Number
2
DI Record Publish Date
June 25, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |