Catalog Number

SCV12CTHFA

Brand Name

CARDINAL HEALTH

Version/Model Number

SCV12CTHFA

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"

Yes

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

NWU

Product Code Name

Kit, introducer, endoscope

Public Device Record Key

a0e16b65-3958-4e71-8d0a-a972b42c754c

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 14, 2015

Package DI Number

50887488030621

Quantity per Package

3

Contains DI Package

00887488030626

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE