Catalog Number

56-15935S1

Brand Name

AXS

Version/Model Number

56-15935S1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171152

Product Code

HBW

Product Code Name

FASTENER, PLATE, CRANIOPLASTY

Public Device Record Key

20507a16-f621-42e7-9479-a78e3d6c7bd4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-