Catalog Number

-

Brand Name

Apogee

Version/Model Number

B1061

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

GBM

Product Code Name

CATHETER, URETHRAL

Public Device Record Key

d1b631e1-dfb5-47b3-83cb-75dde4de4e8c

Public Version Date

June 27, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

10610075176721

Quantity per Package

18

Contains DI Package

00610075176724

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case