FDA.report

SUGITA ANEURYSM CLIP

Primary DI
04946329060874
Brand
SUGITA ANEURYSM CLIP
Company
MIZUHO CORPORATION
Model
07-940-22
Catalog number
07-940-22
Device description
TYPE: LARGE, PERMANENT, No.22 RANGE: 115-160gf(1.13-1.57N) MATERIAL: ISO 5832-7/ASTM F1058G2 BLADE: L-SHAPED MAXIMUM OPENING: 8.0mm GRIP SURFACE: SERRATED
Published
2015-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HCIApplier, Aneurysm Clip

Product Code Classifications

CodeDeviceSpecialtyClass
HCIApplier, Aneurysm ClipNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04946329060874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04946329060874049463290608744946329060874

GMDN Terms

TermDefinition
Aneurysm clip, sterileA sterile, 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.

Device Sizes

TypeValueUnit
Length10Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
9999999999regulatory@mizuho.co.jp

Regulatory Flags

DUNS number
690677802
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04946329173932Operating Table VACB-3006B08-041-2008-041-202025-09-05
04946329308259Operating Table VACB-3006B Type150S08-055-7508-055-752025-09-05
04946329385847Narrow head section08-075-0008-075-002025-09-05
04946329385854Narrow head section08-083-6908-083-692025-09-05
04946329385861Narrow head section08-083-7008-083-702025-09-05
04946329404555Operating Table MST-7300BX18-045-1418-045-142025-09-05
04946329443066Side Rail Clamp (18 mm)08-110-1808-110-182025-06-26
04946329404234Short Boot Extender18-070-5018-070-502025-06-10
04946329416725SUGITA TITANIUM ANEURYSM CLIP II17-002-4017-002-402025-04-25
04946329416732SUGITA TITANIUM ANEURYSM CLIP II17-002-4117-002-412025-04-25
04946329416749SUGITA TITANIUM ANEURYSM CLIP II17-002-4217-002-422025-04-25
04946329416756SUGITA TITANIUM ANEURYSM CLIP II17-002-4317-002-432025-04-25
04946329416763SUGITA TITANIUM ANEURYSM CLIP II17-002-4417-002-442025-04-25
04946329385519Operating Table MOT-VS70018-042-1118-042-112024-11-06
04946329385526Operating Table MOT-VS70018-042-2218-042-222024-11-06
04946329385533Operating Table MOT-VS70018-042-2318-042-232024-11-06
04946329385564Operating Table MOT-VS70018-042-6118-042-612024-11-06
04946329385571Operating Table MOT-VS70018-042-5218-042-522024-11-06
04946329385588Operating Table MOT-5602BW18-042-5318-042-532024-11-06
04946329395310Operating Table MST-7300BX18-042-0218-042-022024-11-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04250603753049LAZICPeter Lazic GmbHHCI2025-08-26
04250603753032LAZICPeter Lazic GmbHHCI2025-08-05
04250603749264LAZICPeter Lazic GmbHHCI2024-10-30
04250603747390LAZICPeter Lazic GmbHHCI2024-08-02
04250603700197LAZICPeter Lazic GmbHHCI2024-02-06
04250603700241LAZICPeter Lazic GmbHHCI2024-02-06
04250603700487LAZICPeter Lazic GmbHHCI2024-02-06
04250603700524LAZICPeter Lazic GmbHHCI2024-02-06
04250603700579LAZICPeter Lazic GmbHHCI2024-02-06
04250603700876LAZICPeter Lazic GmbHHCI2024-02-06
04250603700883LAZICPeter Lazic GmbHHCI2024-02-06
04250603700890LAZICPeter Lazic GmbHHCI2024-02-06
04250603701057LAZICPeter Lazic GmbHHCI2024-02-06
04946329397734Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397741Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397758Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397765Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397772Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397789Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397710Sugita AVM Microclip II ApplierMIZUHO CORPORATIONHCI2023-12-19
04946329397727Sugita AVM Microclip II ApplierMIZUHO CORPORATIONHCI2023-12-19
04946329397888Sugita AVM Microclip ApplierMIZUHO CORPORATIONHCI2023-03-09
04046964725470NOIRAesculap AGHCI2022-05-06
04046964725487NOIRAesculap AGHCI2022-05-06
04046964725494NOIRAesculap AGHCI2022-05-06
04046964725791NOIRAesculap AGHCI2022-05-06
04046964725807NOIRAesculap AGHCI2022-05-06
04046964725814NOIRAesculap AGHCI2022-05-06
04046964725821NOIRAesculap AGHCI2022-05-06
04046964725838NOIRAesculap AGHCI2022-05-06