AccessGUDID - DEVICE: Data Acquisition Service for NAVIS-EX (04987669101421)

GUDID

Device Identifier (DI) Information

Brand Name: Data Acquisition Service for NAVIS-EX
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669101421
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: Data Acquisition Service for NAVIS-EX (hereafter referred to as DAS) acquires data from measurement devices and transfers it to NAVIS-EX. In addition to acquisition of measurement data, DAS registers patients newly registered with the ALScan/CEM-530 to NAVIS-EX.

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?
45724	Eye anterior segment analyser software	An application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the anterior segment of the eye (i.e., cornea, iris, pupil, anterior chamber and lens) performed with an eye anterior segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFJ	System, Image Management, Ophthalmic

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: be427391-a792-4e3b-8921-9edd193c0a13
Public Version Date: September 24, 2018
Public Version Number: 2
DI Record Publish Date: August 03, 2018