TRUMPF MEDICAL - Shuttle 3.6 360 - TRUMPF Medizin Systeme GmbH + Co. KG

Duns Number:330961223

Device Description: Shuttle 3.6 360

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More Product Details

Catalog Number

-

Brand Name

TRUMPF MEDICAL

Version/Model Number

1489491

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

JEA

Product Code Name

TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Device Record Status

Public Device Record Key

5aec95ec-97b4-4289-a42f-3712a9ca6663

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 28, 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