Catalog Number

UA2550

Brand Name

Boss Instruments LightMat Surgical Illuminator

Version/Model Number

012118

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

FDG

Product Code Name

Retractor, Fiberoptic

Public Device Record Key

e291ee58-f9bd-422e-a901-86eca705c71b

Public Version Date

November 05, 2019

Public Version Number

1

DI Record Publish Date

October 28, 2019

Package DI Number

10812432020085

Quantity per Package

5

Contains DI Package

00812432020088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box