Catalog Number

21-353513

Brand Name

ARROW-LOK

Version/Model Number

1

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

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

K100926,K112675

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

552cd6ed-4202-45cd-9cfe-e6a548e8d0b2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-