Device
Guyon Catheter Introducer Curved 43 cm - 17" Tip Size 2.0 mm Stainless Steel
Manufacturer
SURTEX INSTRUMENTS LTD.
SURTEX INSTRUMENTS LTD.
Model: UR-521-02
DI: 05056111304921
Status: New
MRI: MR Conditional
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
Guyon Catheter Introducer Curved 43 cm - 17" Tip Size 2.0 mm Stainless Steel
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
66cde783-8b44-4af0-a361-6fc93642de45
Distribution Status:
In Commercial Distribution
DUNS Number:
216232502
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05056111304921
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46690
Name: Gastro-urological guidewire, reusable
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 reusable device.
FDA Product Codes
FZX
Guide, surgical, instrument