enPuls Version 2.0

Basic Information

• Brand Name: enPuls Version 2.0
• Primary DI: 04053815060109
• Version / Model: 5427-01
• Catalog Number: 5427-01
• Company Name: Zimmer MedizinSysteme GmbH
• Labeler DUNS: 316111251
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 1
• Public Version Date: 2020-10-01
• Public Version Status: New
• Public Device Record Key: 8d6c6149-7a3b-482d-9963-d7b1c9890884

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47790	Electromechanical orthopaedic extracorporeal shock wave therapy system	An assembly of devices designed to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It is typically portable and includes a control unit that uses an electrical current to create kinetic energy (e.g., with a coil gun) which is transferred to a patient's body upon contact (e.g., with a hand-held surface applicator) to produce mechanical shock waves at selected amplitudes and frequencies. It is used to treat soft-tissue pain and inflammation near bones, disorders such as tendinopathies and lateral/medial epicondylitis, and to stimulate osteogenesis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04053815060109	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]