PRIMERA PLASTICS, INC.

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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

Accessory, Surgical Apparel (LYU) (3)

Premarket Exempt

Yes

Clear

Primera Medical Supplies - 00850018739023 Catalog Number : FACE SHIELD-B

Device Description : Disposable Face Shield - Anti Fog

Device Class : 1

Duns Number: 836290700

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 96

Primera Medical Supplies - 00850018739030 Catalog Number : FACE SHIELD

Device Description : Disposable Face Shield - Anti Fog

Device Class : 1

Duns Number: 836290700

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 25

Primera Medical Supplies - 10850018739044 Catalog Number : FACE SHIELD-Y

Device Description : Youth Size Disposable Face Shield - Anti Fog

Device Class : 1

Duns Number: 836290700

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 50

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