AccessGUDID - DEVICE: Final Fit™ (04987669100042)

GUDID

Device Identifier (DI) Information

Brand Name: Final Fit™
Version or Model: 1.12
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669100042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)

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:	No
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?
17702	Ophthalmic excimer laser system	A mains electricity (AC-powered) device assembly in which input energy is used to excite an excimer gas to emit a high-power laser beam intended for corneal ablation (i.e., photorefractive keratectomy) and other ophthalmologic procedures (e.g., surgical creation of a communication between the lacrimal sac and the nasal cavity). It includes a light source and controls/foot-switch, and is typically coupled to a biomicroscope slit lamp or to an indirect ophthalmoscope by a flexible fibreoptic cable. It does not include femtosecond pulsing or fundus imaging technology.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZS	Excimer Laser System

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: No
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: e44439b2-0973-497c-86b9-d399116cea86
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 17, 2014