Catalog Number

7386

Brand Name

SPECTRE

Version/Model Number

IPN913604

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

9a687212-34ca-4a61-be4c-ef37a5571499

Public Version Date

September 25, 2019

Public Version Number

2

DI Record Publish Date

January 22, 2019

Package DI Number

30841156101132

Quantity per Package

5

Contains DI Package

10841156101138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box