Catalog Number

BUC12C

Brand Name

BD Intermittent

Version/Model Number

BUC12C

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

K111405,K111405,K111405

Product Code

GBM

Product Code Name

Catheter, Urethral

Public Device Record Key

e8f5ed56-5c16-445d-bd4e-5ec30166211f

Public Version Date

December 16, 2020

Public Version Number

1

DI Record Publish Date

December 08, 2020

Package DI Number

16948796203865

Quantity per Package

30

Contains DI Package

06948796203868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA