Bio Protech

Basic Information

• Brand Name: Bio Protech
• Primary DI: 00817120020456
• Version / Model: LWSBR48(N)
• Company Name: BIO PROTECH USA, INC.
• Labeler DUNS: 789127011
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-05
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 3b9393e9-e941-414c-87a5-0d13a50a8769

Device Description

LWSBR48(N)- Leadwires, 2 sets, 48'' long, Safety Plug, Black and Red Coloring, 500 sets/ in a case

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
IKD	Cable, Electrode	Physical Medicine	890.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35751	Transcutaneous electrical stimulation lead	A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817120020456	GS1
Package	10817120020453	GS1	Inner Box	250	In Commercial Distribution
Package	20817120020450	GS1	Master Case	2	In Commercial Distribution

Customer Contacts

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