Catalog Number

-

Brand Name

System HeadSTEP Bite Wide

Version/Model Number

P10107-791

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K081218

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

2bd1ba5b-9d2f-46e5-8477-f9ab1c28f5fa

Public Version Date

May 23, 2019

Public Version Number

5

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-