Catalog Number

X-002.88.099

Brand Name

XHL XENON HALOGEN BULB

Version/Model Number

X-002.88.099

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

-

Product Code

ERA

Product Code Name

OTOSCOPE

Public Device Record Key

10ba8d2a-2584-4885-a6e6-5ceba08a9ac1

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-