Catalog Number

SBA12BTHFA

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA12BTHFA

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

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

bc2e3a28-874d-4d3b-92f6-0abc4205e62b

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

November 10, 2016

Package DI Number

50887488093787

Quantity per Package

100

Contains DI Package

10887488093789

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE