Catalog Number

-

Brand Name

DORO® Sterile Disposable Skull Pins

Version/Model Number

3006-00

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193438

Product Code

HBL

Product Code Name

Holder, Head, Neurosurgical (Skull Clamp)

Public Device Record Key

9c33babd-0a18-4b90-98d0-4f5753de2fbf

Public Version Date

July 08, 2021

Public Version Number

6

DI Record Publish Date

December 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-