AccessGUDID - DEVICE: Biowave Percutaneous Electrodes (00859911006027)

GUDID

Device Identifier (DI) Information

Brand Name: Biowave Percutaneous Electrodes
Version or Model: MK78515 - BWEP02-E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOWAVE CORPORATION

Primary DI Number: 00859911006027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005759084 *Terms of Use

Device Description: Biowave Percutaneous Electrode Set - E

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHI	Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061166	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 188f5f2c-28fc-4d40-a6e1-3e1aa56e723d
Public Version Date: December 23, 2019
Public Version Number: 4
DI Record Publish Date: August 01, 2016