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

Locators - 00841439100479 Catalog Number : 109016

Device Description : Couchtop Fixation pieces (2) for use with Elekta Couchtops

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Attachment Bar - 00841439100486 Catalog Number : 109017

Device Description : Reusable non-sterile attachment bar for Posiboard™ 2

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Locators - 00841439100493 Catalog Number : 109018

Device Description : Reusable non-sterile Couchtop Fixation pieces (2)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Posiboard™ - 00841439100509 Catalog Number : 109020

Device Description : Breastboard with head support, adjustable arm supports (2) and wrist support

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Locators - 00841439100516 Catalog Number : 109027

Device Description : Reusable non-sterile Couchtop Fixation pieces (2)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Posiboard™ - 00841439100523 Catalog Number : 109030

Device Description : Breastboard with head support, arm and wrist supports

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Guide Pins - 00841439100530 Catalog Number : 109036

Device Description : For use with Medical Intelligence Couchtop

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Locators - 00841439100547 Catalog Number : 109037

Device Description : Couchtop Fixation pieces (2) for use with Prodigy™ Couchtops

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Locators - 00841439100554 Catalog Number : 109038

Device Description : Couchtop Fixation pieces (2)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Guide Pins - 00841439100561 Catalog Number : 109039

Device Description : Reusable non-sterile guide pins for use with Medical Intelligence Couchtop

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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