Surface Electrode, Single-Pack

Basic Information

• Brand Name: Surface Electrode, Single-Pack
• Primary DI: 00852184003441
• Version / Model: 22-0031
• Company Name: Synapse Biomedical, Inc.
• Labeler DUNS: 138432070
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 15b153c5-1f3e-4bcf-bf3c-3c5a4794ca7e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OIR	Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47809	Intramuscular diaphragm/phrenic nerve electrical stimulation system lead	A non-sterile, insulated metal wire(s) that enables an electrical connection between an intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator (EPG) and the proximal ends of the implanted electrodes to permit the transmission of the electrical pulses and to create a return path to the EPG. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852184003441	GS1