Catalog Number

909-12-K

Brand Name

Distraction Pin , 12MM Pouch

Version/Model Number

909-12

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"

Yes

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

-

Product Code

LYQ

Product Code Name

Accessories, Fixation, Spinal Intervertebral Body

Public Device Record Key

70df0177-4fcd-4c6a-9465-a8462a15ef31

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 06, 2022

Package DI Number

20818614022509

Quantity per Package

10

Contains DI Package

00818614022505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box