Catalog Number

-

Brand Name

Horseshoe Headrest

Version/Model Number

Horseshoe Headrest HFD200 Assembly

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

-

Product Code

HBM

Product Code Name

Headrest, Neurosurgical

Public Device Record Key

d0ff2331-852e-4dd9-9130-faf586ce48b8

Public Version Date

September 10, 2019

Public Version Number

3

DI Record Publish Date

October 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-