Catalog Number

2900I-1050

Brand Name

RAAS Cranial Plating System

Version/Model Number

2900I-1050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 22, 2015

Issuing Agency

In HIBCC

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

-

Product Code

GWO

Product Code Name

Plate, cranioplasty, preformed, alterable

Public Device Record Key

95ffe692-2726-44dd-98cb-77663e6507bb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 18, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-