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) (4) Accessory, Surgical Apparel (LYU) (3) Gown, Examination (FME) (1) Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (HOY) (1) Tape And Bandage, Adhesive (KGX) (1)

Premarket Exempt

No Yes

Clear

ProGear - 00852212003535 Catalog Number :

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

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003542 Catalog Number :

Device Description : Face Shield, Full with 11" Drape, Foam Top, Elastic Headband

Device Class :

Duns Number: 199692794

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 24

ProGear - 00852212003566 Catalog Number :

Device Description : Dry Shield Fluid Resistant Personal Protection Gown

Device Class :

Duns Number: 199692794

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 50

ProGear - 00852212003573 Catalog Number :

Device Description : Earloop Mask with Ribbon Print

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003580 Catalog Number :

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

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003597 Catalog Number :

Device Description : Pink Pre-Assembled Glasses

Device Class :

Duns Number: 199692794

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 10

ProGear - 00852212003627 Catalog Number :

Device Description : Seal-A-Mask Perimeter Seal Attachment for Masks

Device Class :

Duns Number: 199692794

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 250

ProGear - 00852212003634 Catalog Number :

Device Description : Extra Large Disposable Lenses

Device Class :

Duns Number: 199692794

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 50

ProGear - 00852212003641 Catalog Number :

Device Description : Purple Striped Earloop Mask, bulk.

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 300

ProGear - 00852212003658 Catalog Number :

Device Description : Orascoptic Face Shield, Full with Headlight Flap, Foam Top, Elastic Headband (USA).

Device Class :

Duns Number: 199692794

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 24

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