TruLight - Hospital Device - TRUMPF Medizin Systeme GmbH + Co. KG

Duns Number:330961223

Device Description: Hospital Device

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More Product Details

Catalog Number

-

Brand Name

TruLight

Version/Model Number

4038120

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 17, 2016

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

FQP

Product Code Name

Lamp, operating-room

Device Record Status

Public Device Record Key

be93e48e-d82f-4f7b-acf8-9c7ea023465e

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRUMPF MEDIZIN SYSTEME GMBH + CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 624
2 A medical device with a moderate to high risk that requires special controls. 48