SAUVRE INTERNATIONAL, LTD.

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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

Electrode, Cutaneous (GXY) (4) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (2)

Premarket Exempt

Clear

Medical Science Products - 00851610008319 Catalog Number : TS-1211

Device Description : Digital TENS device

Device Class : 2

Duns Number: 080557421

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Medical Science Products - 00851610008326 Catalog Number : COM-TENS

Device Description : Analog TENS device

Device Class :

Duns Number: 080557421

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Medical Science Products - 00864666000305 Catalog Number : 4040-SD

Device Description : Transcutaneous electrical stimulation electrode, Square, 40x40mm

Device Class :

Duns Number: 080557421

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Medical Science Products - 00864666000336 Catalog Number : 5050-FSD

Device Description : Transcutaneous electrical stimulation electrode, Square, 50x50mm, Foam material

Device Class : 2

Duns Number: 080557421

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Medical Science Products - 00864666000343 Catalog Number : 5090-FSD

Device Description : Transcutaneous electrical stimulation electrode, Square, 50x90mm, Foam material

Device Class : 2

Duns Number: 080557421

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Medical Science Products - 00864666000367 Catalog Number : 110150-FSD

Device Description : Transcutaneous electrical stimulation electrode, Butterfly, 110x150mm, Foam material

Device Class :

Duns Number: 080557421

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

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