Catalog Number

-

Brand Name

3.6V PROFESSIONAL SPOT RET & CASE

Version/Model Number

1302-P-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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K893171

Product Code

HKL

Product Code Name

Retinoscope, Ac-Powered

Public Device Record Key

c8882ba9-ced8-4dc3-aabb-17e2580cf741

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-