Home GUDID 04961333221448 PENTAX Medical
Primary DI 04961333221448
Brand PENTAX Medical
Company HOYA CORPORATION
Model OF-B212
Device description PENTAX Medical Cleaning Adapter OF-B212
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) PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat 2 PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04961333221448 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04961333221448 04961333221448 4961333221448
GMDN Terms# Term, Definition table Term Definition Endoscope flushing adaptor, reusable A small attachment designed to be fitted to an endoscope port for flushing of the endoscope’s lumen(s) during post-procedural washing, disinfection and/or sterilization. It is in the form of a plug that may include a button/switch for control of fluid (e.g., sterilant, disinfectant) and/or air through the lumen; it does not include tubing (i.e., not a tubing set). This is a reusable device.
Sterilization Methods# Method table Method High-level Disinfectant Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 691519705 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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 04547410513790 FUJIFILM FUJIFILM CORPORATION PEA 2025-05-31 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 04961333251636 PENTAX Medical HOYA CORPORATION PEA 2024-05-14 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 04961333249183 DEFINA HOYA CORPORATION PEA 2023-10-31 04961333251650 PENTAX Medical HOYA CORPORATION PEA 2023-10-31 04961333252145 PENTAX Medical HOYA CORPORATION PEA 2023-09-20 04961333252169 PENTAX Medical HOYA CORPORATION PEA 2023-09-20 04961333251827 PENTAX Medical HOYA CORPORATION PEA 2023-09-20 04961333251834 PENTAX Medical HOYA CORPORATION PEA 2023-09-20 04961333251841 PENTAX Medical HOYA CORPORATION PEA 2023-09-20 04961333252107 PENTAX Medical HOYA CORPORATION PEA 2023-09-20