Duns Number:690677802
Device Description: TYPE: FENESTRATED, PERMANENT, No.143RANGE: 139-161gf(1.36-1.58N)MATERIAL: ISO 5832-3/ASTM TYPE: FENESTRATED, PERMANENT, No.143RANGE: 139-161gf(1.36-1.58N)MATERIAL: ISO 5832-3/ASTM F136, ISO 5832-2/ASTM F1341G2BLADE: L-SHAPEDMAXIMUM OPENING: 8.5mmGRIP SURFACE: SERRATED
Catalog Number
17-006-37
Brand Name
SUGITA TITANIUM ANEURYSM CLIP II
Version/Model Number
17-006-37
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
2ef48265-ae7a-442e-8890-622d71ef76db
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
-
| 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 |