Catalog Number

9009-823-14

Brand Name

SCANLAN® Minimally-Invasive Instrumentation

Version/Model Number

9009-823-14

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

-

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

HTE

Product Code Name

Elevator

Public Device Record Key

7fc53ba0-19b0-4bea-897e-1917eab2149c

Public Version Date

August 17, 2020

Public Version Number

2

DI Record Publish Date

November 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-