Catalog Number

-

Brand Name

Medtronic - Interface II

Version/Model Number

01

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

K071179

Product Code

HBL

Product Code Name

Holder, Head, Neurosurgical (Skull Clamp)

Public Device Record Key

504e79c0-d58a-4d4c-b2be-9d4cbaf8aafe

Public Version Date

March 05, 2020

Public Version Number

2

DI Record Publish Date

November 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-