Catalog Number

-

Brand Name

DORO LUCENT® Headrest System

Version/Model Number

1101.010

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

K032331

Product Code

HBL

Product Code Name

Holder, Head, Neurosurgical (Skull Clamp)

Public Device Record Key

f6b85cd5-1a87-4466-9367-fcf138d960ae

Public Version Date

July 08, 2021

Public Version Number

5

DI Record Publish Date

December 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-