Photon Bio

GUDID 00860083001208

KENKO PATTO LLC

Transcutaneous electrical stimulation lead
Primary Device ID00860083001208
NIH Device Record Keyb132efac-211e-4243-9220-b95cf89846ba
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhoton Bio
Version Model Number001
Company DUNS094506788
Company NameKENKO PATTO LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860083001208 [Primary]

FDA Product Code

ISAMassager, Therapeutic, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-26

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