Catalog Number

SCA-IN 18 00-N

Brand Name

SCARLET AL-T INSTRUMENTATION

Version/Model Number

SCA-IN 18 00-N

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

FZX

Product Code Name

Guide, Surgical, Instrument

Public Device Record Key

5f0cbbad-f475-4eb4-8a3d-65920f1673eb

Public Version Date

January 10, 2019

Public Version Number

1

DI Record Publish Date

December 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-