Home GUDID 07290019505013 Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE
Primary DI 07290019505013
Brand Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE
Company ZSQUARE LTD
Model 1
Catalog number 200000
Device description Zsquare ENT-Flex Single-Use Shell. A single-use flexilble rhinolaryngoscope sterile from package. To be used with Zsquare ENT-Flex Imaging Core and Zsquare ENT-Flex Console.
Published 2023-02-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
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 07290019505013 Package GS1 5 In Commercial Distribution 07290019505020 Package GS1 20 In Commercial Distribution 07290019505006 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290019505013 07290019505013 7290019505013 07290019505020 07290019505020 7290019505020 07290019505006 07290019505006 7290019505006
GMDN Terms# Term, Definition table Term Definition Flexible video otorhinolaryngoscope, single-use An endoscope with a flexible inserted portion intended for the visual examination of some or all of the ear (external, middle and inner), nasal passages, paranasal sinuses, pharynx, and/or larynx. It is inserted into the body through the appropriate natural orifice and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor (not included); it may include an irrigation/suction channel. This is a single-use device.
Regulatory Flags# DUNS number 600333837 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290019505037 Zsquare ENT-Flex Imaging Core 1 301001 2023-03-23 07290019505044 Zsquare ENT-Flex Console 1 100000US 2023-03-23 07290019505006 Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE 1 200000 2023-02-07
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
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