Kasaby Barraquer 20-30mm Hg Tonometer - OCULAR INSTRUMENTS, INC.

Duns Number:046212387

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More Product Details

Catalog Number

-

Brand Name

Kasaby Barraquer 20-30mm Hg Tonometer

Version/Model Number

OKBT-20-30

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

HKY

Product Code Name

Tonometer, Manual

Device Record Status

Public Device Record Key

ec18b1b2-1d78-425a-b0aa-d63ef45624c5

Public Version Date

September 24, 2018

Public Version Number

3

DI Record Publish Date

December 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OCULAR INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 47