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) (7) Mask, Surgical (FXX) (3)

Premarket Exempt

No Yes

Clear

Precept® - 10814707022978 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 : 15

Precept® - 10814707023142 Catalog Number :

Device Description : Isolation Gown with Tape-tab Neck Closure

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

Precept® - 10814707023159 Catalog Number :

Device Description : Isolation Gown with Tape-tab Neck Closure

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

Precept® - 10814707023333 Catalog Number :

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

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Precept® - 10814707023357 Catalog Number :

Device Description : FluidGard® 160 Anti-Fog Surgical Mask

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 300

Precept® - 10814707023364 Catalog Number :

Device Description : Procedure Mask

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 500

Precept® - 10814707023371 Catalog Number :

Device Description : Isolation Gown with Elastic Cuffs - AAMI 2

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Precept® - 10814707023388 Catalog Number :

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

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Precept® - 10814707029991 Catalog Number :

Device Description : FluidGard® 160 Procedure Mask

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 500

Precept® - 20814707020735 Catalog Number :

Device Description : Isolation Gown with Cuffs

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 30

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