DEVICE: SUGITA TITANIUM ANEURYSM CLIP (04946329060034)
Device Identifier (DI) Information
SUGITA TITANIUM ANEURYSM CLIP
07-934-65
In Commercial Distribution
07-934-65
MIZUHO CORPORATION
07-934-65
In Commercial Distribution
07-934-65
MIZUHO CORPORATION
TYPE: STANDARD, PERMANENT, No.65
RANGE: 130-165gf(1.27-1.62N)
MATERIAL: ISO 5832-3/ASTM F136, ISO 5832-2/ASTM F1341G2
BLADE: SLIGHTLY CURVED
MAXIMUM OPENING: 9.5mm
GRIP SURFACE: SERRATED
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
34958 | Aneurysm clip |
A metallic device intended to be permanently implanted around the neck of an aneurysm (a balloon-like sac formed on a blood vessel) for occlusion, to prevent it from bleeding or bursting and to isolate it from the rest of the vessel. The device is typically an alpha-shaped coil spring, with blades that open like jaws, that comes with a dedicated applier for application to the aneurysm. The device is available in a variety of sizes and its blades may be straight or curved. It is typically used to treat intracranial aneurysms; it may also be used to prevent bleeding from small blood vessels.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HCH | Clip, Aneurysm |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 11 Millimeter |
Device Record Status
80a2841d-d0f9-4e16-8b3d-1afada2499d9
February 05, 2021
5
October 10, 2015
February 05, 2021
5
October 10, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
9999999999
regulatory@mizuho.co.jp
regulatory@mizuho.co.jp