AccessGUDID - DEVICE: ZEPTO Precision Capsulotomy System (B560Z20200)

GUDID

Device Identifier (DI) Information

Brand Name: ZEPTO Precision Capsulotomy System
Version or Model: Z2020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z2020
Company Name: MYNOSYS CELLULAR DEVICES, INC.

Primary DI Number: B560Z20200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827036927 *Terms of Use

Device Description: ZEPTO Disposable Handpiece with Fluid Isolator

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44681	Electrosurgical handpiece, single-use	A 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 inert gas-enhanced electrosurgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUL	Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170655	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64b8d004-81a0-4ab7-95bd-0fd42449e870
Public Version Date: April 04, 2023
Public Version Number: 2
DI Record Publish Date: November 23, 2021