ZEPTO Precision Capsulotomy System Z2020

GUDID B560Z20200

ZEPTO Disposable Handpiece with Fluid Isolator

MYNOSYS CELLULAR DEVICES, INC.

Electrosurgical handpiece, single-use
Primary Device IDB560Z20200
NIH Device Record Key64b8d004-81a0-4ab7-95bd-0fd42449e870
Commercial Distribution StatusIn Commercial Distribution
Brand NameZEPTO Precision Capsulotomy System
Version Model NumberZ2020
Catalog NumberZ2020
Company DUNS827036927
Company NameMYNOSYS CELLULAR DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com
Phone7604565015
Emailnhartman@centricityvision.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB560Z20200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-01
Device Publish Date2021-11-23

On-Brand Devices [ZEPTO Precision Capsulotomy System]

B560Z20200ZEPTO Disposable Handpiece with Fluid Isolator
B560C20200Power Console

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