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) Cap, Surgical (FYF) (3) Non-Surgical Isolation Gown (OEA) (2)

Premarket Exempt

No Yes

Clear

Precept® - 20814707020810 Catalog Number :

Device Description : Over-the-Head Thumb Loop Gown with Elastic Wrists - Open Back

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Precept® - 20814707020841 Catalog Number :

Device Description : Over-the-Head Thumb Loop Gown with Elastic Wrists - Open Back

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Precept® - 20814707020933 Catalog Number :

Device Description : Cleanroom Shoe Covers with Embossed Poly Sole

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 100

Precept® - 20814707020940 Catalog Number :

Device Description : Cleanroom Shoe Covers with Embossed Poly Sole

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 100

Precept® - 20814707020957 Catalog Number :

Device Description : 20" Cleanroom Boot Covers with Embossed Poly Sole

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 100

Precept® - 20814707020964 Catalog Number :

Device Description : 20" Cleanroom Boot Covers with Embossed Poly Sole

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 100

Precept® - 20814707020971 Catalog Number :

Device Description : Nonwoven Shoe Covers

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 300

Precept® - 20814707021015 Catalog Number :

Device Description : Full-face Cleanroom Hood with Snap Closure

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FYF

Prescription Use : No

Device Count : 100

Precept® - 20814707021022 Catalog Number :

Device Description : Full-face Pullover Cleanroom Hood with Ties

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FYF

Prescription Use : No

Device Count : 100

Precept® - 20814707021053 Catalog Number :

Device Description : Legionnaire Surgical Hood with Tape Tab Closure

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : FYF

Prescription Use : No

Device Count : 100

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