Catalog Number

-

Brand Name

UNBRANDED

Version/Model Number

07-KC02

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"

Yes

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

HRM

Product Code Name

MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC

Public Device Record Key

53c87e6b-ec1e-4689-89fa-07769735c2ca

Public Version Date

May 22, 2020

Public Version Number

1

DI Record Publish Date

May 14, 2020

Package DI Number

10848340001960

Quantity per Package

25

Contains DI Package

00848340001963

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-