BladeCARTRIDGE-1 - QLICKSMART PTY LTD

Duns Number:755003498

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More Product Details

Catalog Number

-

Brand Name

BladeCARTRIDGE-1

Version/Model Number

QSSVCAT-1

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

GES

Product Code Name

Blade, Scalpel

Device Record Status

Public Device Record Key

7c0d9db2-75c1-46d1-891f-905db739f4d1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 22, 2017

Additional Identifiers

Package DI Number

29337363001463

Quantity per Package

4

Contains DI Package

19337363001466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton

"QLICKSMART PTY LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 1