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) (10)

Premarket Exempt

No Yes

Clear

ProGear - 00852212003108 Catalog Number :

Device Description : ProGear™ Isolation Mask, Earloop, Green (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003115 Catalog Number :

Device Description : Pro-Lite™ Surgical Mask, Tie, Blue (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003122 Catalog Number :

Device Description : Dry Shield™ Fluid Resistant Mask 160mm, Earloop w/o Visor, Ice Blue (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 40

ProGear - 00852212003139 Catalog Number :

Device Description : Dry Shield™ Fluid Resistant Mask 160mm, Earloop, Anti-Glare/Anti-Fog Visor,

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

ProGear - 00852212003146 Catalog Number :

Device Description : Dry Shield™ Fluid Resistant Mask 160mm, Tie w/o Visor, Ice Blue (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003153 Catalog Number :

Device Description : Dry Shield™ Fluid Resistant Mask 160mm, Tie, Anti-Glare/Anti-Fog Visor, Ice

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

ProGear - 00852212003160 Catalog Number :

Device Description : Skin-Saver™ Sensitive Skin Mask, Earloop, White (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003177 Catalog Number :

Device Description : Skin-Saver™ Sensitive Skin Mask, Tie, White (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003184 Catalog Number :

Device Description : Pro-80™ Fluid Resistant Procedure Mask 80mm, Earloop, Blue (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003191 Catalog Number :

Device Description : Pro-80™ Fluid Resistant Surgical Mask 80mm, Tie, Blue (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

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