Home GUDID 00821925041455 InstaClear
Primary DI 00821925041455
Brand InstaClear
Company Gyrus Acmi, Inc.
Model LCS4K70BTOL
Device description SHEATH, LENS CLEANER ULTRA 70DEG, BOTTOM LIGHT INSTACLEAR
Published 2024-04-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true 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 00821925041455 Package GS1 5 In Commercial Distribution 00821925041523 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 00821925041455 00821925041455 821925041455 0821925041455 00821925041523 00821925041523 821925041523 0821925041523
GMDN Terms# Term, Definition table Term Definition Flexible fibreoptic nasopharyngoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.
Regulatory Flags# DUNS number 007198742 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 false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 04961333221073 PENTAX Medical HOYA CORPORATION EOB 2023-07-31 04961333221448 PENTAX Medical HOYA CORPORATION EOB 2023-07-31 04961333221455 PENTAX Medical HOYA CORPORATION EOB 2023-07-31