UNICO GLOBAL 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) (9) Non-Surgical Isolation Gown (OEA) (1)

Premarket Exempt

No Yes

Clear

DISPOSABLE NITRILE GLOVE - 08809783490303 Catalog Number :

Device Class : 1

Duns Number: 690513726

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : Yes

Device Count : 100

FACE SHIELD MASK - 08809783490310 Catalog Number :

Device Class : 1

Duns Number: 690513726

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : Yes

Device Count : 10

MEDICAL APRON - 08809783490327 Catalog Number :

Device Class : 1

Duns Number: 690513726

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : Yes

Device Count : 50

MEDICAL SCRUB WEAR - 08809783490334 Catalog Number :

Device Class : 1

Duns Number: 690513726

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : Yes

Device Count : 1

SHOES COVER - 08809783490341 Catalog Number :

Device Class : 1

Duns Number: 690513726

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : Yes

Device Count : 1

SURGICAL CAPS - 08809783490402 Catalog Number :

Device Class : 1

Duns Number: 690513726

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : Yes

Device Count : 50

SURGICAL DRAPE - 08809783490419 Catalog Number :

Device Class : 1

Duns Number: 690513726

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : Yes

Device Count : 1

SURGICAL MASK - 08809783490426 Catalog Number :

Device Class : 1

Duns Number: 690513726

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : Yes

Device Count : 50

SURGICAL MASK WITH FACE SHIELD - 08809783490433 Catalog Number :

Device Class : 1

Duns Number: 690513726

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : Yes

Device Count : 25

ISOLSTION GOWN(COVERALL) - 08809783490549 Catalog Number :

Device Class : 1

Duns Number: 690513726

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : Yes

Device Count : 1

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