FDA.reportPublic FDA data

Zepto Capsulotomy System

Primary DI
B560Z10000
Brand
Zepto Capsulotomy System
Company
MYNOSYS CELLULAR DEVICES, INC.
Model
Z1000
Catalog number
Z1000
Device description
Zepto Handpiece
Published
2017-07-19
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
PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B560Z10001PackageHIBCC10In Commercial Distribution
B560Z10000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, single-useA 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
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store at room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5108576296dmarinsik@mynosys.com
5104153245swedgwood@mynosys.com

Regulatory Flags#

DUNS number
827036927
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B560C20230ZeptoLink IOL Positioning SystemC2023C20232023-06-16
B560Z20230ZeptoLinnk IOL Positioning SystemZ2023Z20232023-06-16
B560Z20240ZeptoLinnk IOL Positioning SystemZ2024Z20242023-06-16
B560E10000Zepto Capsulotomy SystemE1000E10002017-07-19
B560C20200ZEPTO Precision Capsulotomy SystemC2020C20202021-11-23
B560Z20200ZEPTO Precision Capsulotomy SystemZ2020Z20202021-11-23
B560124300Zepto Capsulotomy System12430124302017-07-19
B560126840Zepto Capsulotomy System12684126842017-07-19
B560126860Zepto Capsulotomy System12686126862017-07-19
B560E10001Zepto Capsulotomy SystemE1000E10002017-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B560C20230ZeptoLink IOL Positioning SystemMYNOSYS CELLULAR DEVICES, INC.PUL2023-06-16
B560Z20230ZeptoLinnk IOL Positioning SystemMYNOSYS CELLULAR DEVICES, INC.PUL2023-06-16
B560Z20240ZeptoLinnk IOL Positioning SystemMYNOSYS CELLULAR DEVICES, INC.PUL2023-06-16
B560C20200ZEPTO Precision Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2021-11-23
B560Z20200ZEPTO Precision Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2021-11-23
B560E10000Zepto Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2017-07-19
B560124300Zepto Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2017-07-19
B560126840Zepto Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2017-07-19
B560126860Zepto Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2017-07-19
B560E10001Zepto Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2017-07-19