NovoTHOR Gen 3.0 XL PRX

GUDID 05060494130497

S2186 NovoTHOR Gen 3.0 XL PRX

THOR PHOTOMEDICINE LIMITED

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Primary Device ID05060494130497
NIH Device Record Key594d5438-da9c-4bdb-ba51-d74168de510f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovoTHOR Gen 3.0 XL PRX
Version Model Number3.0
Company DUNS856233908
Company NameTHOR PHOTOMEDICINE LIMITED
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 Numbertrue
Manufacturing Datetrue
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
GS105060494130497 [Primary]

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-20
Device Publish Date2020-08-12

Devices Manufactured by THOR PHOTOMEDICINE LIMITED

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05060494130572 - LED Lollipop2021-10-11 S2197 LED Lollipop
05060494130541 - Lollipop Probe2021-05-25 S2197 Lollipop Probe
05060494130558 - 810nm 16W Cluster PRX100 (80x200mW)2021-05-25 S2202 810nm 16W Cluster PRX100 (80x200mW)
05060494130565 - PRX Lollipop Probe2021-05-25 S2196 PRX Lollipop Probe
05060494130503 - NovoTHOR2021-01-18 S2188 NovoTHOR
05060494130510 - NovoTHOR XL2021-01-18 S2190 NovoTHOR XL

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