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: GW3-45A
Catalog: GW3-45A
DI: 08809909421556
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:
5b071ab4-3062-41b7-b4f5-5b79c9b97c8f
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:
08809909421631
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
08809909421556
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08809909421556
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