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

Wrench (HXC) (8) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

No Yes

Clear

Kalitec Universal Instruments - B07301K0180330 Catalog Number : 01-K01-8033

Device Description : Handle, Universal In Line, Double Depth Stop, M3

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0183000 Catalog Number : 01-K01-8300

Device Description : Assembly, Handle, Guidewire Grip

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0360280 Catalog Number : 01-K03-6028

Device Description : Handle, T30 Ratchet, Micro

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380000 Catalog Number : 01-K03-8000

Device Description : Handle, AO, Small, Non-ratcheting

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380010 Catalog Number : 01-K03-8001

Device Description : Handle, AO, External, Non-ratcheting

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380020 Catalog Number : 01-K03-8002

Device Description : Handle, Ratcheting In Line Cannulated, Impact

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380030 Catalog Number : 01-K03-8003

Device Description : Handle, Ratcheting In Line AO Micro

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380200 Catalog Number : 01-K03-8020

Device Description : Handle, Threaded Standard Dynamo

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380220 Catalog Number : 01-K03-8022

Device Description : Handle, Threaded Large Dynamo Impact

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380240 Catalog Number : 01-K03-8024

Device Description : Handle, Threaded Stream Line Impact

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

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