Catalog Number

-

Brand Name

Head Frame Cranial Screws, Short

Version/Model Number

P1008070003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180586,K180586,K180586,K180586

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

1fe44268-20bf-4df5-b782-f626f93f2102

Public Version Date

January 25, 2021

Public Version Number

1

DI Record Publish Date

January 16, 2021

Package DI Number

30858086006277

Quantity per Package

10

Contains DI Package

20858086006270

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case