STERILE Mapping Probe

Basic Information

• Brand Name: STERILE Mapping Probe
• Primary DI: 00852184003090
• Version / Model: 21-0001-99
• 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: 62eb2343-1c43-4d8a-a59d-b68792a39a42

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
47811	Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, return	A sterile implanted non-active wire (an indifferent anode), insulated with non-conductive material except at its electrode(s), used as part of an intramuscular diaphragm/phrenic nerve electrical stimulation system to create a return path for electrical current sent from an external pulse generator (EPG) to the phrenic nerve motor point in the diaphragm. The distal end of the electrode is placed against the internal tissue, and the proximal end protrudes percutaneously to connect to the external pulse generator (EPG) via a cable.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852184003090	GS1