NovoTHOR Gen 3.0 XL - S2190 NovoTHOR Gen 3.0 XL - THOR PHOTOMEDICINE LIMITED

Duns Number:856233908

Device Description: S2190 NovoTHOR Gen 3.0 XL

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More Product Details

Catalog Number

-

Brand Name

NovoTHOR Gen 3.0 XL

Version/Model Number

3.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

1e6dd9fc-50c0-4977-a63b-a6ea36053129

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

August 12, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THOR PHOTOMEDICINE LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 56