PINPOINT PAQ® - Novadaq Technologies Inc

Duns Number:243730939

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More Product Details

Catalog Number

-

Brand Name

PINPOINT PAQ®

Version/Model Number

PP9031

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

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

614163ef-c445-4188-8ddf-eba7c919d64d

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20858701006173

Quantity per Package

6

Contains DI Package

10858701006176

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"NOVADAQ TECHNOLOGIES INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25
3 A medical device with high risk that requires premarket approval 1