Home GUDID 10649111067563 Sklar
Primary DI 10649111067563
Brand Sklar
Company SKLAR CORPORATION
Model 85-1620
Device description OTIS BOUGIE A BOULE 20FR
Published 2023-11-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name FAX BOUGIE, UROLOGICAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FAX Bougie, Urological Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10649111067563 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10649111067563 10649111067563
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 006966006 Device count 1 DM exempt true Premarket exempt true Lot or batch true Serial number 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 00810143905809 SURGIPROS Surgipros, LLC FAX 2026-06-01 00810143905816 SURGIPROS Surgipros, LLC FAX 2026-06-01 00810143905823 SURGIPROS Surgipros, LLC FAX 2026-06-01 00810143905830 SURGIPROS Surgipros, LLC FAX 2026-06-01 00810143905847 SURGIPROS Surgipros, LLC FAX 2026-06-01 00810143905854 SURGIPROS Surgipros, LLC FAX 2026-06-01 00810143905861 SURGIPROS Surgipros, LLC FAX 2026-06-01 00810143905878 SURGIPROS Surgipros, LLC FAX 2026-06-01 00810143905885 SURGIPROS Surgipros, LLC FAX 2026-06-01 00810143905892 SURGIPROS Surgipros, LLC FAX 2026-06-01 00810143905908 SURGIPROS Surgipros, LLC FAX 2026-06-01 00810143905915 SURGIPROS Surgipros, LLC FAX 2026-06-01 04049197548434 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-09-20 04049197548441 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-09-20 04049197181723 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181730 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181754 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181761 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181785 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181792 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181815 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181822 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181846 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181853 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181877 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181884 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181907 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181914 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181938 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28 04049197181945 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28