MEDTEC, INC.

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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

Accelerator, linear, medical (IYE) (10) System, nuclear magnetic resonance imaging (LNH) (5)

Premarket Exempt

No Yes

Clear

Belly Board - 00841439100783 Catalog Number : 125012

Device Description : (carbon fiber)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Belly Board MRI - 00841439100790 Catalog Number : 126000

Device Description : (glass fiber)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

Combifix™ - 00841439100806 Catalog Number : 151002

Device Description : baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and Kne baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and Kneefix™ cushion

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Combifix™ - 00841439100813 Catalog Number : 151003

Device Description : Reusable non-sterile Combifix™ baseplate with (2) elevation blocks, Feetfix™ bra Reusable non-sterile Combifix™ baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and low Kneefix™ cushion

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Combifix™ Baseplate - 00841439100820 Catalog Number : 151014

Device Description : Combifix™ Baseplate

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Attachment Bar - 00841439100837 Catalog Number : 151020

Device Description : Reusable non-sterile attachment bar for Multifix™

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Positioning Cushion - 00841439100844 Catalog Number : 301001

Device Description : Reusable non-sterile head support

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

Positioning Cushion - 00841439100851 Catalog Number : 301002

Device Description : Reusable non-sterile (10.2 x 22.9 x 7.6cm) head support

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

Positioning Cushion - 00841439100868 Catalog Number : 301003

Device Description : Reusable non-sterile (10.2 x 22.9 x 10.2cm) head support

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

Positioning Cushion - 00841439100875 Catalog Number : 301004

Device Description : Reusable non-sterile (10.2 x 22.9 x 8.9cm) head support

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

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