Catalog Number

-

Brand Name

Apogee IC

Version/Model Number

10816

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

010865ca-7b62-4d15-a446-7f3f4024554c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

20610075205145

Quantity per Package

12

Contains DI Package

00610075205141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case