Cystometry Pack - with Rectal Split balloon with Introducer, 8F - Laborie Medical Technologies Canada ULC

Duns Number:203383526

Device Description: with Rectal Split balloon with Introducer, 8F

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More Product Details

Catalog Number

-

Brand Name

Cystometry Pack

Version/Model Number

9021T1021

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FEN

Product Code Name

DEVICE, CYSTOMETRIC, HYDRAULIC

Device Record Status

Public Device Record Key

1543fd5d-22b0-4d08-8869-02a68096e450

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

10627825007303

Quantity per Package

10

Contains DI Package

00627825007290

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"LABORIE MEDICAL TECHNOLOGIES CANADA ULC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 258