Avivatens Pain Management 0439-5006

GUDID 15099058439001

BIO-MEDICAL RESEARCH LIMITED

Transcutaneous electrical stimulation lead
Primary Device ID15099058439001
NIH Device Record Key72bc05b3-a655-4195-a6a2-91ddbdb7bd7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvivatens Pain Management
Version Model Number439, 438, 413
Catalog Number0439-5006
Company DUNS987904356
Company NameBIO-MEDICAL RESEARCH LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099058439001 [Primary]

FDA Product Code

NYNStimulator, Electrical, Transcutaneous, For Arthritis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2016-09-24

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