FDA.reportPublic FDA data

SUGITA TITANIUM ANEURYSM CLIP

Primary DI
04946329060065
Brand
SUGITA TITANIUM ANEURYSM CLIP
Company
MIZUHO CORPORATION
Model
07-934-69
Catalog number
07-934-69
Device description
TYPE: STANDARD, PERMANENT, No.69RANGE: 125-160gf(1.23-1.57N)MATERIAL: ISO 5832-3/ASTM F136, ISO 5832-2/ASTM F1341G2BLADE: CURVEDMAXIMUM OPENING: 8.0mmGRIP SURFACE: SERRATED
Published
2015-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCHClip, Aneurysm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCHClip, AneurysmNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04946329060065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04946329060065049463290600654946329060065

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length9Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999regulatory@mizuho.co.jp

Regulatory Flags#

DUNS number
690677802
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04946329189582Sugita Titanium Clip II Case17-010-8017-010-802022-04-05
04946329206470Sugita Clip Case07-936-6007-936-602022-04-05
04946329376289Sugita Clip Metal Case07-936-6607-936-662022-02-03
04946329376296Sugita Titanium Clip II Metal Case17-010-2017-010-202022-02-03
04946329067682U-shaped Head Rest08-073-0308-073-032021-07-02
04946329067699U-shaped Head Rest08-073-0408-073-042021-07-02
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
04946329058291CP ANGLED SUPER MICRO-DISSECTORS07-821-0507-821-052022-04-17
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

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Primary DI, Brand, Company table
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04946329416725SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
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04946329416749SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416756SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416763SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
G586N697205A0NovosurgicalNOVO SURGICAL, INC.HCH2025-02-06
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G586N6972700NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
04250603707424LAZICPeter Lazic GmbHHCH2024-09-12
04250603726791LAZICPeter Lazic GmbHHCH2024-03-25
04250603727057LAZICPeter Lazic GmbHHCH2024-03-25
00842331190506Novo Surgical Inc. NOVO SURGICAL, INC.HCH2024-01-07
00842331190513Novo Surgical Inc. NOVO SURGICAL, INC.HCH2024-01-07
00842331190520Novo Surgical Inc. NOVO SURGICAL, INC.HCH2024-01-07
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