Catalog Number

-

Brand Name

Speculum Kratz-Barraquer Curved Angled Temporal

Version/Model Number

31-1009

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HNC

Product Code Name

Specula, Ophthalmic

Public Device Record Key

4cd1b751-2086-4c7a-9ec0-6d345e944d0e

Public Version Date

August 09, 2022

Public Version Number

1

DI Record Publish Date

August 01, 2022

Package DI Number

05060745555871

Quantity per Package

10

Contains DI Package

05060745555864

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-