Catalog Number

-

Brand Name

Speculum Leibinger Solid Blade

Version/Model Number

31-3000

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

83fdac2b-fb86-428c-9ac3-57c28f2f7165

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Package DI Number

05060480403000

Quantity per Package

10

Contains DI Package

05060480408395

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-