Home GUDID 00190776163778 Millennium
Primary DI 00190776163778
Brand Millennium
Company Avalign Technologies, Inc.
Model 1-U32206
Device description Malleable Tip Guide Stylet Fr
Published 2021-11-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EZB STYLET FOR CATHETER, GASTRO-UROLOGY
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776163778 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00190776163778 00190776163778 190776163778 0190776163778
GMDN Terms# Term, Definition table Term Definition Filiform urethral bougie 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 792528510 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776421267 Millennium Avalign Technologies, Inc. EZB 2026-05-04 00190776415419 Millennium Avalign Technologies, Inc. EZB 2026-01-27 00190776389789 Millennium Avalign Technologies, Inc. EZB 2024-11-18 00190776307356 Millennium Avalign Technologies, Inc. EZB 2023-11-17 00190776303020 Millennium Avalign Technologies, Inc. EZB 2023-11-16 00190776303341 Millennium Avalign Technologies, Inc. EZB 2023-11-16 00190776302016 Millennium Avalign Technologies, Inc. EZB 2023-11-15 00810143901191 SURGIPROS Surgipros, LLC EZB 2023-09-08 00190776350710 Millennium Avalign Technologies, Inc. EZB 2023-01-10 00190776296933 Millennium Avalign Technologies, Inc. EZB 2022-12-12 00190776163730 Millennium Avalign Technologies, Inc. EZB 2021-11-01 00190776163747 Millennium Avalign Technologies, Inc. EZB 2021-11-01 00190776163754 Millennium Avalign Technologies, Inc. EZB 2021-11-01 00190776163761 Millennium Avalign Technologies, Inc. EZB 2021-11-01 00827002448469 Motion Hybrid Wire Guide HERAEUS MEDICAL COMPONENTS LLC EZB 2021-09-09 00827002448483 Motion Hybrid Wire Guide HERAEUS MEDICAL COMPONENTS LLC EZB 2021-09-09 00827002448490 Motion Hybrid Wire Guide HERAEUS MEDICAL COMPONENTS LLC EZB 2021-09-09 00827002448551 Motion Hybrid Wire Guide HERAEUS MEDICAL COMPONENTS LLC EZB 2021-09-09 00801741051449 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 00801741051456 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 00801741051463 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 00801741051470 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 00801741051487 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 00801741051494 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 00801741051500 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 00801741051517 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 00801741051524 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 00801741051531 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 10801741051446 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 10801741051453 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23