Duns Number:690677802
Device Description: Fukushima Keyhole Clip Applier for Sugita Titanium Clip II Mini Left
Catalog Number
17-015-30
Brand Name
Fukushima Keyhole Clip Applier
Version/Model Number
17-015-30
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
da258f13-e269-4113-af94-1362f4c46d8d
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
-
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 |