Catalog Number

527914J

Brand Name

STABILIZER

Version/Model Number

527914J

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

1eb93ad1-1f1b-4ce4-89be-46c90d8be3b9

Public Version Date

August 01, 2022

Public Version Number

3

DI Record Publish Date

January 26, 2021

Package DI Number

20705032056431

Quantity per Package

5

Contains DI Package

10705032056434

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX