Device
Guyon Catheter Guide Curved, 10" Working Length, 14-1/2" OL 9FR
Manufacturer
Avalign Technologies, Inc.
Model: 1-852360 DI: 00190776421267 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-04 Current Version: 2026-05-12
Description
Guyon Catheter Guide Curved, 10" Working Length, 14-1/2" OL 9FR
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 76a4e507-bdd9-411c-8a23-852ab24818c5
Distribution Status: In Commercial Distribution
DUNS Number: 792528510
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: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00190776421267
Type: Primary
Issuing Agency: GS1
GMDN
Code: 11704
Name: Filiform urethral bougie
Definition:
An extremely thin, wire-like, manual surgical instrument designed for traversing and exploring urethral strictures and/or dilating the urethra, introduced directly or through an appropriately-threaded urethral catheter. The tip of the device can be bent or contoured to shapes that will facilitate the progression of the device through the stricture; the tip may be bulbous (an olive tip). It is typically made of plastic material [e.g., polyvinyl chloride (PVC)] with a threaded metal section. It may be threaded at the proximal end to enable it to connect to a filiform follower (e.g., a larger diameter bougie). This is a single-use device.
FDA Product Codes
EZB
Stylet For Catheter, Gastro-Urology