Soleo Stim 5350

GUDID 04053815003328

Zimmer MedizinSysteme GmbH

Physical therapy electrical stimulation system, line-powered
Primary Device ID04053815003328
NIH Device Record Key79976af8-ea03-4a8c-a733-c30139f43800
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoleo Stim
Version Model Number5350
Catalog Number5350
Company DUNS316111251
Company NameZimmer MedizinSysteme GmbH
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

Customer Support Contacts

Phone(800) 327-3576
Emailinfo@zimmerusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104053815003328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIHInterferential Current Therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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