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)

Premarket Exempt

No Yes

Clear

Arm Support - 00841439100257 Catalog Number : 106023

Device Description : Arm Support - High

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Arm Support - 00841439100264 Catalog Number : 106024

Device Description : Arm Support - Cranial

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Arm Support - 00841439100271 Catalog Number : 106025

Device Description : Arm Support - Adjustable Upper (2)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Bottom Stop - 00841439100295 Catalog Number : 106029

Device Description : Reusable non-sterile bottom stop for use with Posiboard™

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Arm Support - 00841439100301 Catalog Number : 106047

Device Description : Reusable non-sterile set of rigid adjustable arm support with extra large cups

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Arm Support - 00841439100318 Catalog Number : 106048

Device Description : Rigid adjustable (2)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Posirest 2 - 00841439100325 Catalog Number : 106419

Device Description : Posirest 2

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Posirest 2 - 00841439100332 Catalog Number : 106520

Device Description : Baseplate with headrest, high arm support, cranial arm support and adjustable ar Baseplate with headrest, high arm support, cranial arm support and adjustable arm supports (2)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Posirest 2 - 00841439100349 Catalog Number : 106521

Device Description : Baseplate with headrest, high arm support, cranial arm support and rigid adjusta Baseplate with headrest, high arm support, cranial arm support and rigid adjustable arm supports (2)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Posirest 2 - 00841439100356 Catalog Number : 106522

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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