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

Tray, Surgical (LRP) (8) Wrench (HXC) (2)

Premarket Exempt

No Yes

Clear

Universal - B07301K048040 Catalog Number : 01-K04-8040

Device Description : Egg Handle, 1.5 inch Fixed Quarter Square Cannulated

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Universal - B07301K048121 Catalog Number : 01-K04-8121

Device Description : T-Handle, Torque Limiting 60In-lbs, Small Hudson

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0600000 Catalog Number : 01-K06-0000

Device Description : Tray Lid, Universal, Blank

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0600070 Catalog Number : 01-K06-0007

Device Description : Tray Insert, 1.5" Blank

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0602000 Catalog Number : 01-K06-0200

Device Description : Tray base, 2"

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0602250 Catalog Number : 01-K06-0225

Device Description : Tray, Base, 2.25"

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Klitec Universal Instruments - B07301K0603500 Catalog Number : 01-K06-0350

Device Description : Tray, Base, 3.5"

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0604250 Catalog Number : 01-K06-0425

Device Description : Tray, Base, 4.25"

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0604500 Catalog Number : 01-K06-0450

Device Description : Tray, Base, 4.5"

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0606000 Catalog Number : 01-K06-0600

Device Description : Tray, Base, 6"

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

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