Device
Guyon Catheter Guide Curved, 10" Working Length, 14-1/2" OL 9FR
Manufacturer
Avalign Technologies, Inc.
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