Kapp Surgical Instrument Co.

Kapp Surgical Instrument Co.

Address:4919 WARRENSVILLE CENTER RD.,WARRENSVILLE HEIGHTS,OH,44128,US

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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

Prosthesis, Elbow, Hemi-, Radial, Polymer (KWI) (7) Retractor (GAD) (2) Marker, Radiographic, Implantable (NEU) (1)

Premarket Exempt

No Yes

Clear

Rosenkranz Pediatric Open Heart Retractor - B033K216 Catalog Number : K-216

Device Description : Child Malleable Blade

Device Class : 1

Duns Number: 004171112

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Rosenkranz Pediatric Open Heart Retractor - B033K217 Catalog Number : K-217

Device Description : Pediatric malleable blade.

Device Class : 1

Duns Number: 004171112

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Bari Ring - B033K9536N0 Catalog Number :

Device Class :

Duns Number: 004171112

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 3

Seitz Solution Radial Head - B033KCHI1809 Catalog Number : KCHI-1809

Device Description : 18 x 9mm Radial Head

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

Seitz Solution Radial Head - B033KCHI1811 Catalog Number : KCHI-1811

Device Description : 18 x 11mm Radial Head

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

Seitz Solution Radial Head - B033KCHI1813 Catalog Number : KCHI-1813

Device Description : 18 x 13mm Radial Head

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

Seitz Solution Radial Head - B033KCHI2010 Catalog Number : KCHI-2010

Device Description : 20x10mm Radial Head

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

Seitz Solution Radial Head - B033KCHI2012 Catalog Number : KCHI-2012

Device Description : 20x12mm Radial Head

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

Seitz Solution Radial Head - B033KCHI2014 Catalog Number : KCHI-2014

Device Description : 20x14mm Radial Head

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

Seitz Solution Radial Head - B033KCHI2311 Catalog Number : KCHI-2311

Device Description : 23x11mm Radial Head

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

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