FDA.reportPublic FDA data

Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE

Primary DI
07290019505006
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220004000Zsquare ENT-Flex EndoscopeZsquare, Ltd.2022-06-14EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019505013PackageGS15In Commercial Distribution
07290019505020PackageGS120In Commercial Distribution
07290019505006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019505013072900195050137290019505013
07290019505020072900195050207290019505020
07290019505006072900195050067290019505006

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video otorhinolaryngoscope, single-useAn 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.

Contacts#

Phone, Email table
PhoneEmail
+97236987600service@zsquaremedical.com

Regulatory Flags#

DUNS number
600333837
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019505037Zsquare ENT-Flex Imaging Core13010012023-03-23
07290019505044Zsquare ENT-Flex Console1100000US2023-03-23
07290019505013Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE12000002023-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327631395N/ASTRYKER CORPORATIONEOB2026-06-19
07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16
07613327632774N/ASTRYKER CORPORATIONEOB2026-06-16
00840319759011Hayden MedicalHayden Medical, Inc.EOB2026-05-01
04719872715016MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04719872715023MiiS Horus Video BoxMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04961333255238VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255306VIVIDEOHOYA CORPORATIONEOB2025-12-19
00858119004194Entity XL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004200Entity SDXL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004217Entity XL USB NasopharyngoscopeOPTIM LLCEOB2024-06-19
00821925041462InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041479InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041486InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041493InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041509InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041516InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041523InstaClearGyrus ACMI, LLCEOB2024-04-22
04961333239825VIVIDEOHOYA CORPORATIONEOB2024-02-07
07290016539226Colibri micro-ENT Scope3NT MEDICAL LTDEOB2023-12-31
04961333070367PENTAXHOYA CORPORATIONEOB2023-07-31
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04961333077984PENTAXHOYA CORPORATIONEOB2023-07-31
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04961333134052PENTAXHOYA CORPORATIONEOB2023-07-31
04961333134359PENTAXHOYA CORPORATIONEOB2023-07-31
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04961333221073PENTAX MedicalHOYA CORPORATIONEOB2023-07-31
04961333221448PENTAX MedicalHOYA CORPORATIONEOB2023-07-31
04961333221455PENTAX MedicalHOYA CORPORATIONEOB2023-07-31