e∙Sense - e∙Sense Urodynamic catheters are single-use - PendraCare International B.V.

Duns Number:413008652

Device Description: e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters are int e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.

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More Product Details

Catalog Number

37041005

Brand Name

e∙Sense

Version/Model Number

Bladder, Single Sensor Catheter, Straight tip shape

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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 Details

Product Code

FEN

Product Code Name

Device, Cystometric, Hydraulic

Device Record Status

Public Device Record Key

0adc00d6-cf81-4f38-942a-95e4dd793c01

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 01, 2016

Additional Identifiers

Package DI Number

38718122028323

Quantity per Package

10

Contains DI Package

08718122028322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box

"PENDRACARE INTERNATIONAL B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 533