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) (4) System, nuclear magnetic resonance imaging (LNH) (4)

Premarket Exempt

No Yes

Clear

Solstice™ Thermoplastic Frame - 10841439112554 Catalog Number : MTAPCID1832

Device Description : Head-only standard thermoplastic with hair cover

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

Solstice™ Thermoplastic Frame - 10841439112561 Catalog Number : MTAPCIN1832

Device Description : Head-only narrow thermoplastic with hair cover

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE, LNH

Prescription Use : Yes

Device Count : 1

Solstice™ Thermoplastic Frame - 10841439112578 Catalog Number : MTAPCID1832SG

Device Description : Head-only open-face standard thermoplastic with hair cover

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

Solstice™ Thermoplastic Frame - 10841439112585 Catalog Number : MTAPCIN1832SG

Device Description : Head-only open-face narrow thermoplastic with hair cover

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : LNH, IYE

Prescription Use : Yes

Device Count : 1

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