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) (9) Respirator,Surgical (MSH) (1)

Premarket Exempt

No Yes

Clear

Precept® - 10814707020486 Catalog Number :

Device Description : FOAM FOG-SHIELD® SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020493 Catalog Number :

Device Description : TAPE FOG-SHIELD® SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020509 Catalog Number :

Device Description : TAPE FOG-SHIELD® SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020516 Catalog Number :

Device Description : MICROGARD™ SURGICAL MASK WITH EXTENDED SHIELD

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020523 Catalog Number :

Device Description : DUALGARD™ SURGICAL MASK WITH EXTENDED SHIELD

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020530 Catalog Number :

Device Description : DUALGARD™ PROCEDURE MASK WITH EXTENDED SHIELD

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020547 Catalog Number :

Device Description : DUALGARD™ FOAM SHIELD™ ANTI-FOG PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020554 Catalog Number :

Device Description : DUALGARD™ FOAM SHIELD™ SURGICAL MASK WITH STRETCH KNIT TIES

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020578 Catalog Number :

Device Description : COMFORT-CONE™ SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020585 Catalog Number :

Device Description : N95 SURGICAL RESPIRATOR

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : MSH

Prescription Use : No

Device Count : 20

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