DEVICE: SUGITA TITANIUM ANEURYSM CLIP II (04946329137842)

Device Identifier (DI) Information

SUGITA TITANIUM ANEURYSM CLIP II
17-001-51
In Commercial Distribution
17-001-51
MIZUHO CORPORATION
04946329137842
GS1

1
690677802 *Terms of Use
TYPE: TEMPORARY STD, TEMPORARY, No.51 RANGE: 65-75gf(0.64-0.74N) MATERIAL: ISO 5832-3/ASTM F136, ISO 5832-2/ASTM F1341G2 BLADE: STRAIGHT MAXIMUM OPENING: 9mm GRIP SURFACE: SERRATED
CLOSE

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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HCH Clip, Aneurysm
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 7 Millimeter
CLOSE

Device Record Status

3f306b5b-dd78-40e8-a093-01867496f24a
February 05, 2021
5
October 10, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
9999999999
regulatory@mizuho.co.jp
CLOSE