Sugita Titanium Clip II Single Shaft Applier - Sugita Titanium Clip II Single Shaft Applier - MIZUHO CORPORATION

Duns Number:690677802

Device Description: Sugita Titanium Clip II Single Shaft Applier Mini, 90mm

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More Product Details

Catalog Number

17-013-72

Brand Name

Sugita Titanium Clip II Single Shaft Applier

Version/Model Number

17-013-72

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

-

Product Code Details

Product Code

HCI

Product Code Name

Applier, Aneurysm Clip

Device Record Status

Public Device Record Key

803734b3-63fa-477b-9d1d-2e1e367fd901

Public Version Date

April 02, 2020

Public Version Number

3

DI Record Publish Date

June 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIZUHO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 696
2 A medical device with a moderate to high risk that requires special controls. 566