FDA.reportPublic FDA data

Zsquare ENT-Flex Imaging Core

Primary DI
07290019505037
Brand
Zsquare ENT-Flex Imaging Core
Company
ZSQUARE LTD
Model
1
Catalog number
301001
Device description
Zsquare ENT-Flex Imaging Core. Reusable. Hand Held. To be used with Zsquare ENT-flex Single-Use Shell and Zsquare ENT-Flex Console.
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
OEBLung Computed Tomography System, Computer-Aided Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEBLung Computed Tomography System, Computer-Aided DetectionRadiology2

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
07290019505037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019505037072900195050377290019505037

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

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
07290019505044Zsquare ENT-Flex Console1100000US2023-03-23
07290019505006Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE12000002023-02-07
07290019505013Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE12000002023-02-07

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