Catalog Number

-

Brand Name

Apogee

Version/Model Number

11026Q

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

K992137,K992137,K992137

Product Code

GBM

Product Code Name

CATHETER, URETHRAL

Public Device Record Key

29fc5567-a9a4-4f8b-bd8e-2e2ec0ec581c

Public Version Date

July 25, 2022

Public Version Number

1

DI Record Publish Date

July 15, 2022

Package DI Number

00610075068968

Quantity per Package

18

Contains DI Package

00610075068586

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case