Soleo SonoStim 5340

GUDID 04053815003304

Zimmer MedizinSysteme GmbH

Physical therapy ultrasound/neuromuscular stimulation system
Primary Device ID04053815003304
NIH Device Record Keyef9083fd-bd46-42de-bd0b-fc448da525ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoleo SonoStim
Version Model Number5340
Catalog Number5340
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
GS104053815003304 [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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04053815083344 - clTrac2023-06-13
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