Home GUDID 00190776350710 Millennium
Primary DI 00190776350710
Brand Millennium
Company Avalign Technologies, Inc.
Model 1-29328
Device description Female Catheter
Published 2023-01-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 00190776350710 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 00190776350710 00190776350710 190776350710 0190776350710
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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 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 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 00190776163778 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 10801741051446 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 10801741051453 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 10801741051460 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 10801741051477 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 10801741051484 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 10801741051491 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 10801741051507 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 10801741051514 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 10801741051521 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 10801741051538 NiCore Nitinol Guidewire C. R. Bard, Inc. EZB 2020-09-23 00801741049019 Councill Stylet C. R. Bard, Inc. EZB 2020-09-21 00801741049026 Catheter Stylet C. R. Bard, Inc. EZB 2020-09-21 00801741049033 Catheter Stylet C. R. Bard, Inc. EZB 2020-09-21
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