Home GUDID 04961333221073 PENTAX Medical
Primary DI 04961333221073
Brand PENTAX Medical
Company HOYA CORPORATION
Model OE-B9
Device description Leakage test adapter OE-B9
Published 2023-07-31
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 EOB Nasopharyngoscope (Flexible Or Rigid)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04961333221073 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04961333221073 04961333221073 4961333221073
GMDN Terms# Term, Definition table Term Definition Invasive medical device leak tester, mechanical A hand-operated device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It is typically a hand pump (e.g., a bulb) with a manometer and controls intended to be connected to the device tested. This is a reusable device.
Sterilization Methods# Method table Method High-level Disinfectant
Regulatory Flags# DUNS number 691519705 Device count 1 DM exempt true Premarket exempt false 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 07613327631395 N/A STRYKER CORPORATION EOB 2026-06-19 07613327631388 N/A STRYKER CORPORATION EOB 2026-06-16 07613327632774 N/A STRYKER CORPORATION EOB 2026-06-16 00840319759011 Hayden Medical Hayden Medical, Inc. EOB 2026-05-01 04719872715016 MiiS Horus scope MEDIMAGING INTEGRATED SOLUTION INC. EOB 2026-04-29 04719872715023 MiiS Horus Video Box MEDIMAGING INTEGRATED SOLUTION INC. EOB 2026-04-29 04961333255238 VIVIDEO HOYA CORPORATION EOB 2025-12-19 04961333255306 VIVIDEO HOYA CORPORATION EOB 2025-12-19 00858119004194 Entity XL Plus Nasopharyngoscope OPTIM LLC EOB 2024-06-19 00858119004200 Entity SDXL Plus Nasopharyngoscope OPTIM LLC EOB 2024-06-19 00858119004217 Entity XL USB Nasopharyngoscope OPTIM LLC EOB 2024-06-19 00821925041462 InstaClear Gyrus ACMI, LLC EOB 2024-04-22 00821925041479 InstaClear Gyrus ACMI, LLC EOB 2024-04-22 00821925041486 InstaClear Gyrus ACMI, LLC EOB 2024-04-22 00821925041493 InstaClear Gyrus ACMI, LLC EOB 2024-04-22 00821925041509 InstaClear Gyrus ACMI, LLC EOB 2024-04-22 00821925041516 InstaClear Gyrus ACMI, LLC EOB 2024-04-22 00821925041523 InstaClear Gyrus ACMI, LLC EOB 2024-04-22 04961333239825 VIVIDEO HOYA CORPORATION EOB 2024-02-07 07290016539226 Colibri micro-ENT Scope 3NT MEDICAL LTD EOB 2023-12-31 04961333070367 PENTAX HOYA CORPORATION EOB 2023-07-31 04961333075164 PENTAX HOYA CORPORATION EOB 2023-07-31 04961333077984 PENTAX HOYA CORPORATION EOB 2023-07-31 04961333084562 PENTAX HOYA CORPORATION EOB 2023-07-31 04961333134052 PENTAX HOYA CORPORATION EOB 2023-07-31 04961333134359 PENTAX HOYA CORPORATION EOB 2023-07-31 04961333171262 PENTAX HOYA CORPORATION EOB 2023-07-31 04961333221448 PENTAX Medical HOYA CORPORATION EOB 2023-07-31 04961333221455 PENTAX Medical HOYA CORPORATION EOB 2023-07-31 04961333226153 PENTAX HOYA CORPORATION EOB 2023-07-31