Model 30 Pneumatonometer - AC powered contact tonometer intended for the - REICHERT, INC.

Duns Number:126650253

Device Description: AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The device is indicated for use as a screening /monitoring tool for glaucoma or when increased IOP is suspected.

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More Product Details

Catalog Number

-

Brand Name

Model 30 Pneumatonometer

Version/Model Number

16031

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

K002395

Product Code Details

Product Code

HKX

Product Code Name

Tonometer, Ac-Powered

Device Record Status

Public Device Record Key

e0befa64-a569-4718-8854-264d2f67e72e

Public Version Date

July 06, 2018

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