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® - 10814707020288 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® - 10814707020295 Catalog Number :

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

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020301 Catalog Number :

Device Description : PROCEDURE MASK WITH EXTENDED SHIELD

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020318 Catalog Number :

Device Description : FLUIDGARD® 160 LASER SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020325 Catalog Number :

Device Description : FLUIDGARD® 160 ANTI-FOG LASER SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020332 Catalog Number :

Device Description : STANDARD SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020349 Catalog Number :

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

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020356 Catalog Number :

Device Description : FLUIDGARD® 160 GLAREGARD™ SURGICAL MASK WITH ANTI-GLARE SHIELD

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020363 Catalog Number :

Device Description : FluidGard® 120 FluidPouch™ Surgical Mask

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020370 Catalog Number :

Device Description : FluidGard® 120 FluidPouch™ Surgical Mask with Anti-Glare Shield

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

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