Data Acquisition Service for NAVIS-EX - Data Acquisition Service for NAVIS-EX (hereafter - NIDEK CO.,LTD.

Duns Number:690635461

Device Description: Data Acquisition Service for NAVIS-EX (hereafter referred to as DAS) acquires data from me 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.

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More Product Details

Catalog Number

-

Brand Name

Data Acquisition Service for NAVIS-EX

Version/Model Number

1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NFJ

Product Code Name

System, Image Management, Ophthalmic

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NIDEK CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 39
2 A medical device with a moderate to high risk that requires special controls. 73
3 A medical device with high risk that requires premarket approval 5