Alpine Biomed

Basic Information

• Brand Name: Alpine Biomed
• Primary DI: 05704736000581
• Version / Model: 9013S0332
• Company Name: Alpine Biomed ApS
• Labeler DUNS: 311231554
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 5
• Public Version Date: 2020-04-29
• Public Version Status: Update
• Public Device Record Key: a9d0f65e-5bcd-4b13-8803-9bbdd38c8da8
• Distribution End Date: 2020-04-28

Device Description

Large Digital Ring Electrodes, 1.2m lead, TP connectors

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11441	Electromyographic needle electrode, single-use	A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05704736000581	GS1

Premarket Submissions

Submission Number	Supplement Number
K934580	000