TRUMPF MEDICAL - TruSystem 7500 Hybrid MR (FC) - TRUMPF Medizin Systeme GmbH + Co. KG

Duns Number:330961223

Device Description: TruSystem 7500 Hybrid MR (FC)

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More Product Details

Catalog Number

-

Brand Name

TRUMPF MEDICAL

Version/Model Number

2064837

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

GDC

Product Code Name

TABLE, OPERATING-ROOM, ELECTRICAL

Device Record Status

Public Device Record Key

55750ebc-57b4-40ad-9fe4-3d4079eddac7

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 2021

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