Biowave Percutaneous Electrodes

Basic Information

• Brand Name: Biowave Percutaneous Electrodes
• Primary DI: 00859911006003
• Version / Model: MK78505 - BWEP01-B
• Company Name: BIOWAVE CORPORATION
• Labeler DUNS: 005759084
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 4
• Public Version Date: 2019-12-23
• Public Version Status: Update
• Public Device Record Key: 6cc12c72-1775-4a81-a5aa-aeb4c1707c5c

Device Description

Biowave Percutaneous Electrode Set - B

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: 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
NHI	Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60960	Analgesic PENS system probe, single-use	A sterile, hand-held electrical conductor intended to be used as part of an analgesic percutaneous electrical nerve stimulation (PENS) system to deliver controlled electrical impulses directly to subcutaneous tissue for the relief of chronic neuropathic pain. It is intended to be connected to an analgesic PENS system generator and its conductive length introduced percutaneously (invasively) into the patient, in the vicinity of a peripheral nerve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20859911006007	GS1	Case - Perc B	48	In Commercial Distribution
Package	10859911006000	GS1	6-pack zip lock - B	6	In Commercial Distribution
Primary	00859911006003	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K061166	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius