Catalog Number

1488/C

Brand Name

StabiliT®

Version/Model Number

00884450390443

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

ecf89e32-3e99-450d-bfa9-bd1f02ba545e

Public Version Date

July 16, 2021

Public Version Number

1

DI Record Publish Date

July 08, 2021

Package DI Number

10884450390440

Quantity per Package

30

Contains DI Package

00884450390443

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-