Catalog Number

-

Brand Name

Fiber Optic Illuminator

Version/Model Number

1090-001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FDG

Product Code Name

Retractor, Fiberoptic

Public Device Record Key

b6b9da91-9f90-4ca2-8752-b32fb2baaa80

Public Version Date

June 05, 2019

Public Version Number

1

DI Record Publish Date

May 28, 2019

Package DI Number

10869836000342

Quantity per Package

1

Contains DI Package

00869836000345

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case