Catalog Number

1266.XD

Brand Name

Spare bulb for REF: 1266.XIII Xenon BrightStar illumination System.

Version/Model Number

1266.XD

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062895

Product Code

MPA

Product Code Name

Endoilluminator

Public Device Record Key

4fc6a1c0-ab08-4dca-9788-9c81c44878f0

Public Version Date

January 21, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-