Catalog Number

AC0101Y

Brand Name

Y MMLL + Tuohy Borst 9 FR (11G)

Version/Model Number

AC0101Y

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

GBX

Product Code Name

Catheter, Irrigation

Public Device Record Key

a4bfd7fd-604b-4763-82d7-2215b4f2fa04

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

03700512985495

Quantity per Package

16

Contains DI Package

03700512975496

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 2