Catalog Number

-

Brand Name

MAYFIELD®

Version/Model Number

439A1043

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

K130389,K050319,K081401,K090506

Product Code

HBL

Product Code Name

HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Public Device Record Key

48a15c72-98ed-485e-a149-984c07fe3ad3

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

August 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-