Multi Radiance Medical

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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

Lamp, Infrared, Therapeutic Heating (ILY) (10) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (1)

Premarket Exempt

No Yes

Clear

TerraQuant - 00852556007114 Catalog Number : U800

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

TerraQuant - 00852556007121 Catalog Number : 800

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

TerraQuant - 00852556007138 Catalog Number : 850-108

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : GZJ, ILY

Prescription Use : Yes

Device Count : 1

TerraQuant - 00852556007145 Catalog Number : 850-113

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

TerraQuant - 00852556007152 Catalog Number : 850-114

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

TruDenta - 00852556007169 Catalog Number : U801

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

MR4 - 00852556007176 Catalog Number : U600G

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

MR4 - 00852556007183 Catalog Number : U600-300G

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

GameDay - 00852556007190 Catalog Number : U300-200G

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

MR4 - 00852556007206 Catalog Number : 600G

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

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