DEVICE: Sugita Keyhole Applier (04946329061666)
Device Identifier (DI) Information
Sugita Keyhole Applier
07-941-20
In Commercial Distribution
07-941-20
MIZUHO CORPORATION
07-941-20
In Commercial Distribution
07-941-20
MIZUHO CORPORATION
Sugita Keyhole Applier, Straight 13cm Shaft Length for Standard/Large Clips
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
32591 | Aneurysm clip applier |
A surgical instrument designed for the application/insertion of aneurysm clips (devices for approximating the edges of the neck of an aneurysm or for the prevention of bleeding from small individual blood vessels). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HCI | Applier, Aneurysm Clip |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 165.0 Millimeter |
Device Record Status
e6e8eedd-5bcf-46fd-ab8b-78da72f2ae24
April 01, 2020
3
October 10, 2015
April 01, 2020
3
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