Medical Science Products COM-TENS

GUDID 00851610008326

Analog TENS device

SAUVRE INTERNATIONAL, LTD.

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID00851610008326
NIH Device Record Key5b73e5fe-8c99-47d5-8736-50eda0d82bc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedical Science Products
Version Model NumberCOM-TENS
Catalog NumberCOM-TENS
Company DUNS080557421
Company NameSAUVRE INTERNATIONAL, LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Height20 Millimeter
Height20 Millimeter
Height20 Millimeter
Height20 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100851610008326 [Primary]
GS100851610008333 [Package]
Package: Bag [1 Units]
In Commercial Distribution
GS110851610008330 [Package]
Contains: 00851610008333
Package: Box [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2018-05-29

On-Brand Devices [Medical Science Products]

00864666000367Transcutaneous electrical stimulation electrode, Butterfly, 110x150mm, Foam material
10851610008002Transcutaneous electrical stimulation electrode, Square, 50x90mm, Foam material
10864666000395Transcutaneous electrical stimulation electrode, Square, 50x50mm, Foam material
10864666000326Transcutaneous electrical stimulation electrode, Square, 40x40mm
00851610008326Analog TENS device
10851610008347Digital TENS device
10851610008026Transcutaneous electrical stimulation electrode, Square, 50x50mm, Cloth material

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