EndoPuls 811 5435

GUDID 04053815088332

Zimmer MedizinSysteme GmbH

Electromechanical orthopaedic extracorporeal shock wave therapy system
Primary Device ID04053815088332
NIH Device Record Key62faf20b-7121-44ef-98ef-0f04e3b69d35
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoPuls 811
Version Model Number1650903
Catalog Number5435
Company DUNS316111251
Company NameZimmer MedizinSysteme GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Identifiers

Device Issuing AgencyDevice ID
GS104053815088332 [Primary]

FDA Product Code

ISAMassager, Therapeutic, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-25
Device Publish Date2025-03-17

Devices Manufactured by Zimmer MedizinSysteme GmbH

04053815088325 - Endolaser HP2025-03-25
04053815088332 - EndoPuls 8112025-03-25
04053815088332 - EndoPuls 8112025-03-25
04053815087410 - ZStim2024-08-06
04053815086369 - ZShape2024-07-29
04053815087229 - Cryo 72024-06-04
04053815076711 - MFG-052023-10-24
04053815081296 - ThermoTK2023-06-13
04053815083344 - clTrac2023-06-13

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