PRESTIGE AMERITECH, LTD.

Address:7201 Iron Horse Blvd.,North Richland Hills,TX,76180,US

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Filters

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) (3) Respirator, Surgical (MSH) (1)

Premarket Exempt

No Yes

Clear

Communicator - 00852212003665 Catalog Number :

Device Description : Surgical Facemask with Clear Window, ASTM Level 3

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 40

ProGear - 00852212003672 Catalog Number :

Device Description : Clear-View Surgical face Mask with Clear Window, ASTM Level 3

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

ProGear - 00852212003689 Catalog Number :

Device Description : N95 Surgical Mask Respirator with Comfort Strip, Regluar

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : MSH

Prescription Use : No

Device Count : 50

ProGear - 00852212003702 Catalog Number :

Device Description : Metal-Free Mask, Earloop, Lawn Tan

Device Class :

Duns Number: 199692794

Premarket Exempt : Yes

Product Code : FXX

Prescription Use : No

Device Count : 40

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