Catalog Number

7386

Brand Name

SPECTRE

Version/Model Number

IPN914920

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

29ef8b97-cde5-4a1b-98a6-e21055e016cb

Public Version Date

January 18, 2021

Public Version Number

2

DI Record Publish Date

July 01, 2020

Package DI Number

20841156106505

Quantity per Package

5

Contains DI Package

10841156106508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box