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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

Device, medical examination, ac powered (KZF) (9) SURGICAL TABLE CUSHION (LWG) (1)

Premarket Exempt

No Yes

Clear

HexaLux - 00724995167790 Catalog Number : EXLWALL

Device Description : The HexaLux Wall-Mount Light is a powerful, next-generation LED exam light desig

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

HexaLux - 00724995167806 Catalog Number : EXLCEIL

Device Description : The HexaLux Ceiling-Mount Light is a powerful, next-generation LED exam light de

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

HexaLux - 00724995167820 Catalog Number : EXLMBWB

Device Description : The HexaLux Exam Mobile Light with Batteries is a powerful, next-generation LED

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

NA - 00724995169534 Catalog Number : BF768

Device Description : Welded Seam 2-inch Cushion is used with the CMAX X-Ray Image-Guided Table

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

HexaLux - 00724995172459 Catalog Number : EXLMBWBUS

Device Description : The HexaLux Exam Light on Mobile Stand with Batteries is a powerful, next-gener

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

HexaLux - 00724995172466 Catalog Number : EXLMNBHUS

Device Description : The HexaLux Exam Mobile Light without Batteries is a powerful, next-generation

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

HexaLux - 00724995172473 Catalog Number : EXLMWBHUS

Device Description : The HexaLux Mobile Stand with Batteries is used with the HexaLux Light.

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

HexaLux - 00724995172480 Catalog Number : EXLCEBH

Device Description : The HexaLux Ceiling Mounted Light is a powerful, next-generation LED exam light

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

HexaLux - 00724995172497 Catalog Number : EXLWABH

Device Description : The HexaLux Wall-Mount Light is a powerful, next-generation LED exam light desig

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

HexaLux - 00724995172527 Catalog Number : EXLMBNBUS

Device Description : The HexaLux Exam Mobile Light without Batteries is a powerful, next-generation L

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

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