AccessGUDID - DEVICE: VICTUS VERAFIT Patient Interface Kit (04050555004165)

GUDID

Device Identifier (DI) Information

Brand Name: VICTUS VERAFIT Patient Interface Kit
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 90000200TPV
Company Name: Technolas Perfect Vision GmbH

Primary DI Number: 04050555004165
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 341325716 *Terms of Use

Device Description: Patient Interface Kit for VICTUS™ Femtosecond Laser Platform (software version 2.7 and higher). Kit consists of Patient Interface and Suction Clip 125.

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):	No
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?
41707	Laser beam delivery unit holder	A device designed to be used together with a laser delivery unit to provide support to the delivery unit during the operation of the laser. The holder will help with the positioning of the final laser beam output and increase safety from inadvertent movement which would be undesirable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQF	Laser, Ophthalmic
OOE	Ophthalmic Femtosecond Laser

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed73ca1f-e7e8-4715-9a58-472c012468b7
Public Version Date: March 14, 2024
Public Version Number: 5
DI Record Publish Date: December 05, 2016