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) (8) Accessory, Surgical Apparel (LYU) (2)

Premarket Exempt

No Yes

Clear

ProGear - 00852212003344 Catalog Number :

Device Description : Imprints™ Earloop Economy (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003368 Catalog Number :

Device Description : FM85020 ProGear™ Mask, Isolation, Ear loop, Imprints™

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003375 Catalog Number :

Device Description : FM85121-CCM1 ProGear® Imprints-Cook Children's Medical Tie on Mask

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003382 Catalog Number :

Device Description : FM83120 ProGear Skin-Saver Ultra Sensitive Tie-On, White

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003399 Catalog Number :

Device Description : FM83130 ProGear Skin-Saver Ultra Mask Tie, Anti fog foam strip,White (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Eta - 00852212003405 Catalog Number :

Device Description : SURGICAL EARLOOP FACE MASK WITH BOTTOM GAP SHIELD

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 40

ProGear - 00852212003498 Catalog Number :

Device Description : Clear-View Surgical Face Mask with Clear Window

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

ProGear - 00852212003504 Catalog Number :

Device Description : Face Shield with Headlight Flap, Foam Top, Elastic Headband

Device Class :

Duns Number: 199692794

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 24

ProGear - 00852212003511 Catalog Number :

Device Description : I-Gard

Device Class :

Duns Number: 199692794

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 50

Eta - 00852212003528 Catalog Number :

Device Description : Eye Shield Earloop Mask - ASTM Level 2

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 40

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