Catalog Number

-

Brand Name

Cranial Screw - Short

Version/Model Number

P1008070001

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

K142560,K142560,K142560,K142560

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

f5c84c1f-de1f-4ae0-a912-724ce1241fd8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 10, 2016

Package DI Number

20899475002145

Quantity per Package

2

Contains DI Package

10899475002148

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box