Catalog Number

17-015-33

Brand Name

Fukushima Keyhole Clip Applier

Version/Model Number

17-015-33

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

HCI

Product Code Name

Applier, Aneurysm Clip

Public Device Record Key

7ae06a51-85aa-4f4b-8009-039267879e7f

Public Version Date

April 03, 2020

Public Version Number

3

DI Record Publish Date

October 10, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-