Catalog Number

ST1-1026

Brand Name

Stephens Instruments

Version/Model Number

ST1-1026

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

-

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

d4fd3baf-0f90-4394-b81d-9a3b90221de5

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-