Duns Number:656249554
Device Description: The Surgical Mask is intended to be worn to protect both the patient and healthcare person The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile.
Catalog Number
-
Brand Name
UNIWEB SURGICAL MASK
Version/Model Number
ASTM Level 2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K210513,K210513,K210513
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
48cfb111-0c1b-445a-a136-716ebcf0523e
Public Version Date
January 11, 2022
Public Version Number
1
DI Record Publish Date
January 03, 2022
Package DI Number
14715243610147
Quantity per Package
40
Contains DI Package
04715243610140
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
40Boxes/Carton