GENESYS MATRYX - GENESYS MATRYX 11.0 X 35 MM INTERFERENCE SCREW - Conmed Corporation

Duns Number:071595540

Device Description: GENESYS MATRYX 11.0 X 35 MM INTERFERENCE SCREW

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More Product Details

Catalog Number

231135M5

Brand Name

GENESYS MATRYX

Version/Model Number

231135M5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 21, 2018

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

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

-

Product Code Details

Product Code

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

3a3da381-cec7-4376-b170-1aec540e2b8d

Public Version Date

June 22, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95