Catalog Number

614459

Brand Name

BIB®

Version/Model Number

614459

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

K161451

Product Code

NVM

Product Code Name

Catheter, angioplasty, peripheral, transluminal, dual-balloon

Public Device Record Key

f9c89468-833f-4783-9114-725880d01dde

Public Version Date

June 19, 2020

Public Version Number

7

DI Record Publish Date

October 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-