Device
The Guidewire is used to provide access to GI tract for the purpose of passing or exchanging endoscopic accessories.
Manufacturer
TAEWOONGMEDICAL.CO.,LTD
TAEWOONGMEDICAL.CO.,LTD
Model: GW2-26S
Catalog: GW2-26S
DI: 08809909421587
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
The Guidewire is used to provide access to GI tract for the purpose of passing or exchanging endoscopic accessories.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1d85e4dd-70b8-404b-ba7c-3735b4d3cfed
Distribution Status:
In Commercial Distribution
DUNS Number:
689484322
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
08809909421662
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
08809909421587
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08809909421587
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 46691
Name: Gastro-urological guidewire, single-use
Definition:
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.
FDA Product Codes
OCY
Endoscopic Guidewire, Gastroenterology-Urology