Kalitec Direct LLC

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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

Tap, Bone (HWX) (7) Instrument, Compression (HWN) (1) Orthopedic Manual Surgical Instrument (LXH) (1) Screwdriver (HXX) (1)

Premarket Exempt

No Yes

Clear

Klaitec Special - B073DRK0100150 Catalog Number : DR-K01-0015

Device Description : Counter Torque, Low Profile Assembly

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kalitec Special - B073DRK0100160 Catalog Number : DR-K01-0016

Device Description : Compressor, Canoe

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HWN

Prescription Use : Yes

Device Count : 1

Kalitec Special - B073DRK0100170 Catalog Number : DR-K01-0017

Device Description : SNII Tap, 5.50mm

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Kalitec Special - B073DRK0100180 Catalog Number : DR-K01-0018

Device Description : SNII Tap, 6.50mm

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Kalitec Special - B073DRK0100190 Catalog Number : DR-K01-0019

Device Description : SNII Tap, 7.50mm

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Kalitec Special - B073DRK0100200 Catalog Number : DR-K01-0020

Device Description : SNII Screwdriver, Poly Std Assembly

Device Class : 1

Duns Number: 041956211

Premarket Exempt : No

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Kalitec Special - B073DRK0100210 Catalog Number : DR-K01-0021

Device Description : SNII Awl Tap, 5.50mm

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Kalitec Special - B073DRK0100220 Catalog Number : DR-K01-0022

Device Description : SNII Awl Tap, 6.50mm

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Kalitec Special - B073DRK0100230 Catalog Number : DR-K01-0023

Device Description : SNII Awl Tap, 7.50mm

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Kalitec Special - B073DRK0100240 Catalog Number : DR-K01-0024

Device Description : SNII Tap, 4.50mm

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

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