C-WIRE - C-WIRE PAK DOUBLE ENDED ORTHOPAEDIC WIRE, SPADE, - Conmed Corporation

Duns Number:071595540

Device Description: C-WIRE PAK DOUBLE ENDED ORTHOPAEDIC WIRE, SPADE, .035 INCH (0.89MM), QTY 5

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More Product Details

Catalog Number

00505024200

Brand Name

C-WIRE

Version/Model Number

00505024200

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

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

K142134,K142134,K142134

Product Code Details

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Device Record Status

Public Device Record Key

2e775a8a-9408-42fe-ba37-7d624632943a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 14, 2015

Additional Identifiers

Package DI Number

20845854033316

Quantity per Package

5

Contains DI Package

10845854033319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"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