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) (8)

Premarket Exempt

No Yes

Clear

Uni-frame® Thermoplastic - 10841439103842 Catalog Number : MTAPUR2.4

Device Description : Reloadable 25.4cm standard perforation thermoplastic (2.4mm)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

Uni-frame® Thermoplastic - 10841439103859 Catalog Number : MTAPUW

Device Description : 25.4cm extra wide standard perforation thermoplastic (3.2mm)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

Uni-frame® Thermoplastic - 10841439103866 Catalog Number : MTAPUW122.4

Device Description : 30.5cm extra wide standard perforation thermoplastic (2.4mm)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

Uni-frame® Thermoplastic - 10841439103873 Catalog Number : MTAPUW2.4

Device Description : 25.4cm extra wide standard perforation thermoplastic (2.4mm)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

Nasion Cushion - 10841439104221 Catalog Number : MTHF016

Device Description : For use with trUpoint ARCH™

Device Class :

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Bite Cup - 10841439104245 Catalog Number : MTHF135

Device Description : For use with trUpoint ARCH™

Device Class :

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

HipFix® Thermoplastic - 10841439104276 Catalog Number : MTHFI1822

Device Description : 45.7 x 55.9cm IMRT thermoplastic (3.2mm)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

HipFix® Thermoplastic - 10841439104283 Catalog Number : MTHFI18222.4

Device Description : 45.7 x 55.9cm IMRT thermoplastic (2.4mm)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

HipFix® Thermoplastic - 10841439104290 Catalog Number : MTHFX1822

Device Description : 45.7 x 55.9cm standard perforated thermoplastic (3.2mm)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

HipFix® Thermoplastic - 10841439104306 Catalog Number : MTHFX18222.4

Device Description : 45.7 x 55.9cm standard perforated thermoplastic (2.4mm)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

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