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® - 10814707020387 Catalog Number :

Device Description : FLUIDGARD® 120 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® - 10814707020394 Catalog Number :

Device Description : COMFORT-COOL™ SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020400 Catalog Number :

Device Description : COMFORT-PLUS™ SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020417 Catalog Number :

Device Description : COMFORT-PLUS™ SURGICAL MASK WITH STRETCH KNIT TIES

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020424 Catalog Number :

Device Description : COMFORT-PLUS™ SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020431 Catalog Number :

Device Description : COMFORT-PLUS™ SURGICAL MASK WITH STRETCH KNIT TIES

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020448 Catalog Number :

Device Description : SENSITIVE SKIN PLUS SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020455 Catalog Number :

Device Description : HIGH FILTRATION SURGICAL MASK WITH STRETCH KNIT TIES

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020462 Catalog Number :

Device Description : TAPE FOG-SHIELD® LASER MASK WITH STRETCH KNIT TIES

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020479 Catalog Number :

Device Description : DUAL-GARD™ HIGH FILTRATION SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

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