BioCollar 00

GUDID B3670030

Cutaneous Electrode Garment

AXIOBIONICS

Transcutaneous electrical stimulation electrode
Primary Device IDB3670030
NIH Device Record Key27105b5a-4916-4703-8fe5-b3e9dd3fdd33
Commercial Distribution Discontinuation2017-02-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBioCollar
Version Model Number3
Catalog Number00
Company DUNS033139835
Company NameAXIOBIONICS
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB3670030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [BioCollar]

B3670040Cutaneous Electrode Garment
B3670030Cutaneous Electrode Garment

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