Catalog Number

BF038

Brand Name

NA

Version/Model Number

Multi-poise Headrest

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2020

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

-

Product Code

HBL

Product Code Name

HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Public Device Record Key

24e720ea-ee8b-465f-a690-b72699acd81d

Public Version Date

July 08, 2021

Public Version Number

5

DI Record Publish Date

September 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-