Catalog Number

SOT33VBCEB

Brand Name

CARDINAL HEALTH

Version/Model Number

SOT33VBCEB

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

KOA

Product Code Name

SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Public Device Record Key

5a15d4a0-feb2-4eae-82b7-cfa30b66bcba

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

Package DI Number

50195594734716

Quantity per Package

15

Contains DI Package

10195594734718

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE