Catalog Number

SSD4 1116

Brand Name

Stephens Instruments

Version/Model Number

SSD4 1116

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

HND

Product Code Name

Spatula, ophthalmic

Public Device Record Key

c393040b-abd9-485b-bffe-0ba7cb809e29

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Package DI Number

00810799039385

Quantity per Package

10

Contains DI Package

00810799039392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box