B&L Engineering Active EMG Surface Electrode

Basic Information

• Brand Name: B&L Engineering Active EMG Surface Electrode
• Primary DI: 00855144007046
• Version / Model: BL-AE-N/NG
• Company Name: PINSCO, INC.
• Labeler DUNS: 079605952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7f23bb3a-033f-4b70-97bb-6880e2d6f4ed

Device Description

Active EMG Surface Electrode Narrow Spaced - No Ground

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
IKN	Electromyograph, Diagnostic	Physical Medicine	890.1375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36728	Electromyographic signal amplifier	An electronic device used with an electromyograph (EMG) to increase voltage, current, or power. This GMDN code may reflect old technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855144007046	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K952655	000