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) (10)

Premarket Exempt

No Yes

Clear

Kalitec Universal Instruments - B07301K0380260 Catalog Number : 01-K03-8026

Device Description : Handle, Stream Line, Threaded, Impact, Cannulated

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380300 Catalog Number : 01-K03-8030

Device Description : Handle, Threaded In Line, Plastic M8

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380420 Catalog Number : 01-K03-8042

Device Description : Egg Handle, 1.75" Fixed, Quarter Square, Cannulated, Impact

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380600 Catalog Number : 01-K03-8060

Device Description : Egg Handle, Threaded, 1.5"

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380820 Catalog Number : 01-K03-8082

Device Description : T-Handle, Ratcheting, Cannulated, Impact

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380830 Catalog Number : 01-K03-8083

Device Description : T-Handle, Ratcheting, Quarter Square Collar

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380840 Catalog Number : 01-K03-8084

Device Description : T-Handle, Primal, Large, Impact, Quarter Square, Cannulated

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0380850 Catalog Number : 01-K03-8085

Device Description : T-Handle, Stealth, Quarter Square, Impact

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0381200 Catalog Number : 01-K03-8120

Device Description : T-Handle, Torque, 90 in-lbs

Device Class : 1

Duns Number: 041956211

Premarket Exempt : No

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0381220 Catalog Number : 01-K03-8122

Device Description : Egg Handle, Torque, 30 in-lbs

Device Class : 1

Duns Number: 041956211

Premarket Exempt : No

Product Code : HXC

Prescription Use : Yes

Device Count : 1

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