Catalog Number

17-006-35

Brand Name

SUGITA TITANIUM ANEURYSM CLIP II

Version/Model Number

17-006-35

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HCH

Product Code Name

Clip, Aneurysm

Public Device Record Key

f49c1e1f-5ba6-4c08-9b9c-cc600000f3b6

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 10, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-