Model 30™ Tip and Membrane Assembly for Pneumatonometer - Ten (10) replacement tip and membrane assemblies - REICHERT, INC.

Duns Number:126650253

Device Description: Ten (10) replacement tip and membrane assemblies that attach to the Model 30 Pneumatonomet Ten (10) replacement tip and membrane assemblies that attach to the Model 30 Pneumatonometer probe. Probe tip touches a patient's cornea during the measurement.

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More Product Details

Catalog Number

-

Brand Name

Model 30™ Tip and Membrane Assembly for Pneumatonometer

Version/Model Number

230678

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

HKX

Product Code Name

Tonometer, Ac-Powered

Device Record Status

Public Device Record Key

528eec58-5a74-4a23-b2c9-24212c87f53c

Public Version Date

March 29, 2018

Public Version Number

2

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