810nm 200mW Standard Tip - PRX100

GUDID 05060494130411

S2099 810nm 200mW Standard Tip - PRX100

THOR PHOTOMEDICINE LIMITED

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Primary Device ID05060494130411
NIH Device Record Key6357362d-9e8e-460c-aa60-19bd71038c94
Commercial Distribution StatusIn Commercial Distribution
Brand Name810nm 200mW Standard Tip - PRX100
Version Model Number2.3
Company DUNS856233908
Company NameTHOR PHOTOMEDICINE LIMITED
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 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
GS105060494130411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2019-10-11
Device Publish Date2019-10-03

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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