Temena

Basic Information

• Brand Name: Temena
• Primary DI: 03700339710508
• Version / Model: 07050-02
• Catalog Number: 07050-02
• Company Name: Temena GmbH
• Labeler DUNS: 329515725
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-12
• Public Version: 3
• Public Version Date: 2018-04-25
• Public Version Status: Update
• Public Device Record Key: b55f9a94-e590-4fe2-b83b-fe50ddb497ba

Device Description

Cable for peripheral Nerve Block Stimulator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	868.2775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62216	Intramuscular injection site nerve-locating/electromyography system	A portable, electrically-powered device intended to produce electrical impulses for electrical nerve stimulation and to obtain and display electromyography (EMG) readings (visual and/or audio) to locate nerves and muscle, to facilitate accurate intramuscular injection of neuromodulator drugs. It is typically used in multi-focal areas (e.g., neck, hand), and consists of an electrical stimulator with EMG reader in a noninvasive unit (electrodes not included) which typically includes input cables and connectors.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700339710508	GS1