Bio Protech

Basic Information

• Brand Name: Bio Protech
• Primary DI: 00817120020784
• Version / Model: DR
• Company Name: BIO PROTECH USA, INC.
• Labeler DUNS: 789127011
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-08
• Public Version: 3
• Public Version Date: 2018-06-11
• Public Version Status: Update
• Public Device Record Key: ec9591b3-c212-47f7-90d5-ef6247521b26

Device Description

DR: Monopolar single use pencil,rocker switch; spatula electrode; L 3 m (1 pc per pack, 25 packs in a inner box, 50 packs in a master 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GXZ	Electrode, Needle	Neurology	882.1350	2
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	890.1385	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11441	Electromyographic needle electrode, single-use	A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817120020788	GS1	Master Case	2	In Commercial Distribution
Package	10817120020781	GS1	Inner Box	25	In Commercial Distribution
Primary	00817120020784	GS1

Customer Contacts

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