Biowave Percutaneous Electrodes

GUDID 10859911006024

Biowave Percutaneous Electrode Set - E

BIOWAVE CORPORATION

Analgesic PENS system probe, single-use
Primary Device ID10859911006024
NIH Device Record Key188f5f2c-28fc-4d40-a6e1-3e1aa56e723d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiowave Percutaneous Electrodes
Version Model NumberMK78515 - BWEP02-E
Company DUNS005759084
Company NameBIOWAVE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-246-9283
Emailinfo@biowave.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100859911006027 [Primary]
GS110859911006024 [Package]
Contains: 00859911006027
Package: 6-pack zip lock - E [6 Units]
In Commercial Distribution
GS120859911006021 [Package]
Package: Case - Perc E [72 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHIStimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2016-08-01

On-Brand Devices [Biowave Percutaneous Electrodes]

10859911006024Biowave Percutaneous Electrode Set - E
20859911006007Biowave Percutaneous Electrode Set - B

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