Macro Depth Electrode

Basic Information

• Brand Name: Macro Depth Electrode
• Primary DI: 00841823100528
• Version / Model: BF08R-SP21X-0B0
• Catalog Number: BF08R-SP21X-0B0
• Company Name: Ad-Tech Medical Instrument Corporation
• Labeler DUNS: 174813410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2023-08-23
• Public Version Status: Update
• Public Device Record Key: 0c4c6db0-8d1c-415d-ad66-5b21a6ddefb6

Device Characteristics

• Single Use: Yes
• 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: 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
GZL	ELECTRODE, DEPTH	Neurology	882.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32556	Depth electrode	An electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841823100528	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: To be stored and used within typical hospital/office room ambient temperature and humidity conditions