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

MR4 - 00852556007015 Catalog Number : U600

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

MR4 - 00852556007022 Catalog Number : 600

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

MR4 - 00852556007039 Catalog Number : 650-108

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : GZJ, ILY

Prescription Use : Yes

Device Count : 1

MR4 - 00852556007046 Catalog Number : 650-113

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

MR4 - 00852556007053 Catalog Number : 650-114

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

MR4 - 00852556007060 Catalog Number : 650-116

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

MR4 - 00852556007077 Catalog Number : U600-300

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

TerraQuant - 00852556007084 Catalog Number : U800-300

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

PainAway - 00852556007091 Catalog Number : U300-110

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

GameDay - 00852556007107 Catalog Number : U300-200

Device Class : 2

Duns Number: 826320694

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

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