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

Cover, Shoe, Operating-Room (FXP) (5) Non-Surgical Isolation Gown (OEA) (4) Gown, Examination (FME) (1)

Premarket Exempt

No Yes

Clear

Precept® - 20814707021695 Catalog Number :

Device Description : Bootcovers

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 150

Precept® - 20814707021701 Catalog Number :

Device Description : Isolation Gown with Elastic Cuffs

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Precept® - 20814707021718 Catalog Number :

Device Description : Isolation Gown with Knit Cuffs

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Precept® - 20814707021725 Catalog Number :

Device Description : Isolation Gown with Knit Cuffs

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Precept® - 20814707021732 Catalog Number :

Device Description : Isolation Gown with Knit Cuffs

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Precept® - 20814707021756 Catalog Number :

Device Description : 3/4 Sleeve Patient Gown

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 100

Precept® - 20814707022050 Catalog Number :

Device Description : Safe-T-Tread Shoe Cover - Non-Conductive

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 300

Precept® - 20814707022074 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® - 20814707022081 Catalog Number :

Device Description : Safe-T-Tread Shoe Cover - Non-Conductive

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 300

Precept® - 20814707022098 Catalog Number :

Device Description : Safe-T-Tread Shoe Cover - Non-Conductive

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 300

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