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 - 00852212003009 Catalog Number :

Device Description : Clear-View™ Anti-Fog Film Strip Mask, Tie, Green (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003016 Catalog Number :

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

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003023 Catalog Number :

Device Description : Clear-View™ Anti-Fog Tape Strip Mask, Tie, Green (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003030 Catalog Number :

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

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003047 Catalog Number :

Device Description : Pro-80™ Horizontal Tie, Fluid Resistant Mask 80mm, Anti-Glare/Anti-Fog Viso

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

ProGear - 00852212003054 Catalog Number :

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

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003061 Catalog Number :

Device Description : Pro-80™ Duckbill Fluid Resistant Mask 80mm, Tie, Anti-Glare/Anti-Fog Visor,

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

ProGear - 00852212003078 Catalog Number :

Device Description : Clear-View™ Anti-Fog Foam Strip Mask, Tie, Green (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003085 Catalog Number :

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

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003092 Catalog Number :

Device Description : ProGear™ Procedure Mask, Earloop, Blue (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

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