Catalog Number

M-1550

Brand Name

V. Mueller

Version/Model Number

M-1550

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

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

-

Product Code

HBL

Product Code Name

HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Public Device Record Key

c82d5e89-49d0-4a49-89ca-38bb56793338

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

20885403056885

Quantity per Package

12

Contains DI Package

70885403056880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box