PRECEPT MEDICAL PRODUCTS, 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

Non-Surgical Isolation Gown (OEA) (6) Cover, Shoe, Operating-Room (FXP) (1)

Premarket Exempt

No Yes

Clear

Precept® - 20814707022104 Catalog Number :

Device Description : Shoe Cover - Non-Conductive

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 300

Precept® - 20814707022210 Catalog Number :

Device Description : Blue Film Gown

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Precept® - 20814707022227 Catalog Number :

Device Description : Blue Film Gown

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Precept® - 20814707022364 Catalog Number :

Device Description : Isolation Gown

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Precept® - 20814707022654 Catalog Number :

Device Description : Chemotherapy Gown with Knit Cuffs

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 30

Precept® - 20814707022715 Catalog Number :

Device Description : Blue Film Gown with Thumb Loop

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Precept® - 20814707023095 Catalog Number :

Device Description : Blue Film Gown with Thumb Loop

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

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