Catalog Number

-

Brand Name

MR/X-ray HFD (HFD 200)

Version/Model Number

HFD 200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K113748

Product Code

HBL

Product Code Name

Holder, Head, Neurosurgical (Skull Clamp)

Public Device Record Key

5e0ebec0-ce0b-4c47-a871-97eed26229a5

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

September 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-