FDA.reportPublic FDA data

Zsquare ENT-Flex Console

Primary DI
07290019505044
Brand
Zsquare ENT-Flex Console
Company
ZSQUARE LTD
Model
1
Catalog number
100000US
Device description
square ENT-Flex Console. Reusable. To be used with Zsquare ENT-flex Single-Use Shell and Zsquare ENT-Flex Imaging Core. Contains illumination source, cart, foot switch, keyboard, monitor and CCU with accompanying software. Enables live imaging, snapshot and video recording.
Published
2023-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
07290019505044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019505044072900195050447290019505044

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing/light source systemA mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
600333837
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019505037Zsquare ENT-Flex Imaging Core13010012023-03-23
07290019505006Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE12000002023-02-07
07290019505013Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE12000002023-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04580826925948VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
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04961333255528PENTAX MedicalHOYA CORPORATIONEOB2026-08-25
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07613327631395N/ASTRYKER CORPORATIONEOB2026-06-19
07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16