Clearmask, LLC

Address:320 W 29th St,Baltimore,MD,21211,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mask, Surgical (FXX) (1)

Premarket Exempt

Clear

ClearMask - 00860005106028 Catalog Number :

Device Description : Box of 24 masks; Note: individual masks are NOT for sale. Intended use: The Clea 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.

Device Class :

Duns Number: 080991401

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 24

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