Duns Number:080991401
Device Description: Box of 24 masks; Note: individual masks are NOT for sale. Intended use: The ClearMask Tran Box of 24 masks; Note: individual masks are NOT for sale. Intended use: The ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas.The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided sterile.
Catalog Number
-
Brand Name
ClearMask
Version/Model Number
v1.0
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200576,K200576,K200576,K200576
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
8c176c7d-f577-4bdd-9bbc-295ace2cb365
Public Version Date
November 30, 2020
Public Version Number
1
DI Record Publish Date
November 20, 2020
Package DI Number
10860005106025
Quantity per Package
18
Contains DI Package
00860005106028
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case