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enPuls Version 2.0

FDA UDI

Class I (US FDA UDI)

by Zimmer MedizinSysteme GmbH

Identity

Trade Name
enPuls Version 2.0 FDA UDI
Generic Name
Electromechanical orthopaedic extracorporeal shock wave therapy system FDA UDI
Model / Reference
5427-01 FDA UDI

Identifiers

Catalog Number
5427-01 FDA UDI
Primary DI / UDI-DI
04053815060109 FDA UDI
FDA Product Code
ISA FDA UDI
GMDN Term
Electromechanical orthopaedic extracorporeal shock wave therapy system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electromechanical orthopaedic extracorporeal shock wave therapy system

enPuls Version 2.0 by Zimmer MedizinSysteme GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromechanical orthopaedic extracorporeal shock wave therapy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zimmer MedizinSysteme GmbH

Sources (1)

  • FDA UDI 8d6c6149-7a3b-482d-9963-d7b1c9890884 34 fields · synced May 30, 2026