tangoRS™ multifunctional posterior system - tangoRS rod, blue, Ø 6.0 mm, length 65 mm - Ulrich GmbH & Co. KG

Duns Number:315494757

Device Description: tangoRS rod, blue, Ø 6.0 mm, length 65 mm

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More Product Details

Catalog Number

CS 3008-065

Brand Name

tangoRS™ multifunctional posterior system

Version/Model Number

CS 3008-065

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K052385

Product Code Details

Product Code

MNH

Product Code Name

Orthosis, spondylolisthesis spinal fixation

Device Record Status

Public Device Record Key

09e02faf-59ab-4d43-b921-eab98fd27ee4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ULRICH GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1439