Catalog Number

-

Brand Name

Extension Line, 90 cm

Version/Model Number

9021P6322

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FEN

Product Code Name

DEVICE, CYSTOMETRIC, HYDRAULIC

Public Device Record Key

f2895c58-60a5-4d52-a5f1-d17fe18a2b53

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

30627825007307

Quantity per Package

60

Contains DI Package

20627825007300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-