Catalog Number

SSD1 1010

Brand Name

Stephens Instruments

Version/Model Number

SSD1 1010

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

647e8aa4-e338-423b-8d89-5143d31fd6e4

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Package DI Number

00810799039163

Quantity per Package

10

Contains DI Package

00810799039170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box