XWIRE - XWIRE Next Generation Guidewire, 450cm, Stiff - Conmed Corporation

Duns Number:071595540

Device Description: XWIRE Next Generation Guidewire, 450cm, Stiff Wire, Straight Tip

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More Product Details

Catalog Number

035450SS

Brand Name

XWIRE

Version/Model Number

035450SS

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

K011759,K011759,K011759

Product Code Details

Product Code

OCY

Product Code Name

Endoscopic guidewire, gastroenterology-urology

Device Record Status

Public Device Record Key

9655b11a-3eea-41ba-a407-35e736e5be9b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10653405053934

Quantity per Package

3

Contains DI Package

20653405053931

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