AccessGUDID - DEVICE: XWIRE (20653405053894)

GUDID

Device Identifier (DI) Information

Brand Name: XWIRE
Version or Model: 035450S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 035450S
Company Name: Conmed Corporation

Primary DI Number: 20653405053894
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: XWire® Biliary Guidewire 450 cm Straight Tip, .89 mm Guidewire Length, Standard Wire, .035" O.D.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46691	Gastro-urological guidewire, single-use	A metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCY	Endoscopic guidewire, gastroenterology-urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011759	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 450 Centimeter
Outer Diameter: 0.035 Inch
Outer Diameter: 0.89 Millimeter

Device Record Status

Public Device Record Key: 81892405-7be3-446b-9286-7e3c65a2ec90
Public Version Date: December 23, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016