Catalog Number

DF-4011L/A

Brand Name

StabiliT®

Version/Model Number

00884450296417

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

e706a4c8-f9e6-4109-94c7-248e51f0d0b0

Public Version Date

April 09, 2018

Public Version Number

1

DI Record Publish Date

March 09, 2018

Package DI Number

10884450296414

Quantity per Package

22

Contains DI Package

00884450296417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-