VISUPLAN 500 - AC-powered, non-contact tonometer indicated for - REICHERT, INC.

Duns Number:126650253

Device Description: AC-powered, non-contact tonometer indicated for measuring intraocular pressure (IOP) to ai AC-powered, non-contact tonometer indicated for measuring intraocular pressure (IOP) to aid in the screening and diagnosis of glaucoma. An air puff is used to momentarily flatten a patient's cornea during the measurement.

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More Product Details

Catalog Number

-

Brand Name

VISUPLAN 500

Version/Model Number

16080

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

K990869

Product Code Details

Product Code

HKX

Product Code Name

Tonometer, Ac-Powered

Device Record Status

Public Device Record Key

5f957036-35ea-4da3-9a6c-c26fa455e555

Public Version Date

November 09, 2020

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"REICHERT, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22