Home GUDID B560E10001 Zepto Capsulotomy System
Primary DI B560E10001
Brand Zepto Capsulotomy System
Company MYNOSYS CELLULAR DEVICES, INC.
Model E1000
Catalog number E1000
Device description Zepto Fluid Isolator
Published 2017-07-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name PUL Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PUL Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B560E10001 Package HIBCC 10 In Commercial Distribution B560E10000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Electrosurgical handpiece, single-use A sterile hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during argon-enhanced electrosurgery. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry Special Storage Condition, Specify 0 0 Store at room temperature
Regulatory Flags# DUNS number 827036927 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false 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 DI, Brand, Model table Primary DI Brand Model Catalog Published B560C20230 ZeptoLink IOL Positioning System C2023 C2023 2023-06-16 B560Z20230 ZeptoLinnk IOL Positioning System Z2023 Z2023 2023-06-16 B560Z20240 ZeptoLinnk IOL Positioning System Z2024 Z2024 2023-06-16 B560E10000 Zepto Capsulotomy System E1000 E1000 2017-07-19 B560C20200 ZEPTO Precision Capsulotomy System C2020 C2020 2021-11-23 B560Z20200 ZEPTO Precision Capsulotomy System Z2020 Z2020 2021-11-23 B560124300 Zepto Capsulotomy System 12430 12430 2017-07-19 B560126840 Zepto Capsulotomy System 12684 12684 2017-07-19 B560126860 Zepto Capsulotomy System 12686 12686 2017-07-19 B560Z10000 Zepto Capsulotomy System Z1000 Z1000 2017-07-19
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B560C20230 ZeptoLink IOL Positioning System MYNOSYS CELLULAR DEVICES, INC. PUL 2023-06-16 B560Z20230 ZeptoLinnk IOL Positioning System MYNOSYS CELLULAR DEVICES, INC. PUL 2023-06-16 B560Z20240 ZeptoLinnk IOL Positioning System MYNOSYS CELLULAR DEVICES, INC. PUL 2023-06-16 B560C20200 ZEPTO Precision Capsulotomy System MYNOSYS CELLULAR DEVICES, INC. PUL 2021-11-23 B560Z20200 ZEPTO Precision Capsulotomy System MYNOSYS CELLULAR DEVICES, INC. PUL 2021-11-23 B560E10000 Zepto Capsulotomy System MYNOSYS CELLULAR DEVICES, INC. PUL 2017-07-19 B560124300 Zepto Capsulotomy System MYNOSYS CELLULAR DEVICES, INC. PUL 2017-07-19 B560126840 Zepto Capsulotomy System MYNOSYS CELLULAR DEVICES, INC. PUL 2017-07-19 B560126860 Zepto Capsulotomy System MYNOSYS CELLULAR DEVICES, INC. PUL 2017-07-19 B560Z10000 Zepto Capsulotomy System MYNOSYS CELLULAR DEVICES, INC. PUL 2017-07-19
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