Catalog Number

10-10-8530

Brand Name

Coral

Version/Model Number

10-10-8530

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2015

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

-

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Public Device Record Key

965e6753-9d72-4992-bca1-7a499ab35d6a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 18, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-