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) (9)

Premarket Exempt

No Yes

Clear

HipFix® Thermoplastic - 10841439104313 Catalog Number : MTHFX18222.4S

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

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

HipFix® Thermoplastic - 10841439104320 Catalog Number : MTHFX1822S

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

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

HipFix® Thermoplastic - 10841439107024 Catalog Number : MTPLHA0201

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

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

HipFix® Thermoplastic - 10841439107031 Catalog Number : MTPLHA0202

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 - 10841439107048 Catalog Number : MTPLHAI0203

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

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

Type-S™ Thermoplastic - 10841439108861 Catalog Number : MTVRT20

Device Description : Vision RT 3.2mm

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Uni-frame® Thermoplastic - 10841439108878 Catalog Number : MTVRTR

Device Description : Reloadable, Vision RT 3.2mm

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

Uni-frame® Thermoplastic - 10841439108885 Catalog Number : MTVRTW

Device Description : Vision RT 3.2mm wide

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

Posicast® Thermoplastic - 10841439110154 Catalog Number : 960030

Device Description : PR3 Non-Perfo mask

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

Mastercast™ Pro - 10841439110161 Catalog Number : 990044

Device Description : LPR44 mask with profiles

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

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