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

Mask, Surgical (FXX) (10)

Premarket Exempt

No Yes

Clear

Precept® - 10814707020189 Catalog Number :

Device Description : FluidGard® 120 Horizontal Tie Surgical Mask

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020196 Catalog Number :

Device Description : FluidGard® 120 Horizontal Tie Surgical Mask with Anti-Glare Shield

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020202 Catalog Number :

Device Description : FLUIDGARD® 160 PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020219 Catalog Number :

Device Description : FLUIDGARD® 160 ANTI-FOG PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020226 Catalog Number :

Device Description : FLUIDGARD® 160 ANTI-FOG PROCEDURE MASK WITH EXTENDED SHIELD

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020233 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 : 50

Precept® - 10814707020240 Catalog Number :

Device Description : FLUIDGARD® 160 ANTI-FOG SURGICAL MASK WITH EXTENDED SHIELD

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020257 Catalog Number :

Device Description : FLUIDGARD® 160 PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020264 Catalog Number :

Device Description : FLUIDGARD® 160 ANTI-FOG PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020271 Catalog Number :

Device Description : FLUIDGARD® 160 ANTI-FOG PROCEDURE MASK WITH ANTI-GLARE SHIELD

Device Class : 2

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

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