SYNFIX Evolution - SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/15MM - Synthes GmbH

Duns Number:486711679

Device Description: SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/15MM HEIGHT/18°

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More Product Details

Catalog Number

03835374

Brand Name

SYNFIX Evolution

Version/Model Number

03.835.374

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)

Yes

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

HWT

Product Code Name

TEMPLATE

Device Record Status

Public Device Record Key

e6e19b11-38d7-4454-a440-27e804e25352

Public Version Date

April 27, 2022

Public Version Number

4

DI Record Publish Date

June 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNTHES GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8630
2 A medical device with a moderate to high risk that requires special controls. 16671
U Unclassified 2