PINPOINT - Camera - Novadaq Technologies Inc

Duns Number:243730939

Device Description: Camera

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

PC9002

Brand Name

PINPOINT

Version/Model Number

PC9002

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150956

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

c3ce47ab-f7d3-44cf-a0f0-338b5ca01bb9

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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