Urocap IV Light - Wireless Battery Powered Uroflowmeter, Tablet - Laborie Medical Technologies Canada ULC

Duns Number:203383526

Device Description: Wireless Battery Powered Uroflowmeter, Tablet

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More Product Details

Catalog Number

-

Brand Name

Urocap IV Light

Version/Model Number

UCL2000

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"

-

For Single-Use

-

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

EXY

Product Code Name

UROFLOWMETER

Device Record Status

Public Device Record Key

95df5363-c8be-4589-a030-b19386f36ad0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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