Catalog Number

1472/A

Brand Name

StabiliT®

Version/Model Number

00884450296226

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

4a28541c-f54c-4c76-a8bc-7c9866c467df

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 16, 2018

Package DI Number

10884450296223

Quantity per Package

75

Contains DI Package

00884450296226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-