Home GUDID 00810143905847 SURGIPROS
Primary DI 00810143905847
Brand SURGIPROS
Company Surgipros, LLC
Model 85-1616SP
Device description OTIS BOUGIE A BOULE 16FR
Published 2026-06-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false 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 00810143905847 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 00810143905847 00810143905847 810143905847 0810143905847
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 058689193 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false 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 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 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 04049197181969 RZ Medizintechnik GmbH RZ-Medizintechnik GmbH FAX 2024-06-28
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