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) (2)

Premarket Exempt

No Yes

Clear

Posifix® -1 Baseplate - 00841439100141 Catalog Number : 101019

Device Description : 1BD acrylic baseplate

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

Posifix® -2 Baseplate - 00841439100158 Catalog Number : 102011

Device Description : Reusable non-sterile carbon fiber baseplate for five point fixation

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Posifix® -2 Baseplate - 00841439100165 Catalog Number : 102021

Device Description : Carbon fiber baseplate for five point fixation

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Posifix® -4 Baseplate - 00841439100172 Catalog Number : 104021

Device Description : 4BD carbon fiber baseplate

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Posifix® -5 Baseplate - 00841439100189 Catalog Number : 105021

Device Description : 5BD acrylic baseplate

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

Arm Support - 00841439100202 Catalog Number : 106011

Device Description : Reusable non-sterile high arm support

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Arm Support - 00841439100219 Catalog Number : 106015

Device Description : Reusable non-sterile set of rigid adjustable arm supports

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Arm Support - 00841439100226 Catalog Number : 106016

Device Description : Reusable non-sterile set of adjustable arm supports

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Arm Support - 00841439100233 Catalog Number : 106017

Device Description : Reusable non-sterile cranial arm support

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Arm Support - 00841439100240 Catalog Number : 106020

Device Description : Rigid adjustable(2)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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