FDA.report

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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OEBLung Computed Tomography System, Computer-Aided Detection

Product Code Classifications

CodeDeviceSpecialtyClass
OEBLung Computed Tomography System, Computer-Aided DetectionRadiology2

Premarket Submissions

SubmissionSupplement
K220004000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K220004000Zsquare ENT-Flex EndoscopeZsquare, Ltd.2022-06-14EOB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290019505037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290019505037072900195050377290019505037

GMDN Terms

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

Contacts

PhoneEmail
+97236987600service@zsquaremedical.com

Regulatory Flags

DUNS number
600333837
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
07290019505044Zsquare ENT-Flex Console1100000US2023-03-23
07290019505013Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE12000002023-02-07

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