Premier Guard Usa, LLC

Address:4341 Highway 80,Pelahatchie,MS,39145,US

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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)

Premarket Exempt

Clear

ASTM Level 2 Surgical Face Mask - 00850019294002 Catalog Number :

Device Description : 3-ply, single-use disposable surgical mask with an ASTM Level 2 rating. Made wit 3-ply, single-use disposable surgical mask with an ASTM Level 2 rating. Made with elastic ear loops that do not contain natural rubber latex. Carton 50 pcs

Device Class :

Duns Number: 117537165

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ASTM Level 3 Surgical Face Mask - 00850019294019 Catalog Number :

Device Description : 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made wit 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear loops that do not contain natural rubber latex. Carton 50 pcs

Device Class :

Duns Number: 117537165

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Face Mask - 00850019294026 Catalog Number :

Device Description : Case of 3-Ply, single use, disposable face mask. Made with elastic ear loops tha Case of 3-Ply, single use, disposable face mask. Made with elastic ear loops that do not contain natural rubber latex.

Device Class : 2

Duns Number: 117537165

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

ASTM Level 3 Surgical Face Mask - 00850019294156 Catalog Number :

Device Description : Case of 3-Ply, single use, disposable surgical face masks with an ASTM Level 3 r Case of 3-Ply, single use, disposable surgical face masks with an ASTM Level 3 rating. Made with elastic ear loops that do not contain natural rubber latex.

Device Class : 2

Duns Number: 117537165

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

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