PRECEPT MEDICAL PRODUCTS, INC.

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) (8) General Surgery Tray (LRO) (2)

Premarket Exempt

No Yes

Clear

Precept® - 00814707020564 Catalog Number :

Device Description : FATHERS KIT

Device Class : 2

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

Precept® - 00814707020700 Catalog Number :

Device Description : Patient Welcome Kit

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

Precept ® - 10814707020004 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® - 10814707020011 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® - 10814707020028 Catalog Number :

Device Description : PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020035 Catalog Number :

Device Description : PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020042 Catalog Number :

Device Description : PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020059 Catalog Number :

Device Description : PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020066 Catalog Number :

Device Description : KITTYKARE PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020073 Catalog Number :

Device Description : CHILDREN’S FACE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 75

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