FDA.reportPublic FDA data

SUGITA TITANIUM ANEURYSM CLIP II

Primary DI
04946329416756
Brand
SUGITA TITANIUM ANEURYSM CLIP II
Company
MIZUHO CORPORATION
Model
17-002-43
Catalog number
17-002-43
Device description
"TYPE: STANDARD, PERMANENT, No.V03RANGE: 158-182gf(1.55-1.78N)MATERIAL: ISO 5832-3/ASTM F136, ISO 5832-2/ASTM F1341G2BLADE: T-SHAPEMAXIMUM OPENING: 8.5mmGRIP SURFACE: SERRATED"""
Published
2025-04-25
Public version status
New
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
04946329416756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04946329416756049463294167564946329416756

GMDN Terms#

Term, Definition table
TermDefinition
Aneurysm clipA 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
DM exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04946329056440CEA Scissors 170 mm, 35 deg. Downward Cvd07-501-0107-501-012026-05-29
04946329056457CEA Scissors 180 mm, Sideward Cvd.07-501-0207-501-022026-05-29
04946329056464CEA Micro Scissors 170 mm, 35 deg. Downward Cvd.07-501-0307-501-032026-05-29
04946329056471CEA Thin Needle Holder 170 mm07-501-1107-501-112026-05-29
04946329056488CEA Micro Forceps 180 mm, Cvd.07-501-2107-501-212026-05-29
04946329056495CEA Micro Forceps 180 mm, L Str.07-501-2207-501-222026-05-29
04946329056501CEA Micro Forceps 150 mm, S Str.07-501-2307-501-232026-05-29
04946329058802Yasargil micro raspatory, curved, 18.5 cm07-839-0007-839-002026-05-29
04946329058987Micro Scissors 130 mm, FH07-862-0007-862-002026-05-29
04946329077476Pediatric Mosquito Applier without Hook Str09-230-0309-230-032026-05-29
04946329077582Bulldog Clamp 82 mm, L Str.09-259-0109-259-012026-05-29
04946329077599Bulldog Clamp 67 mm, S Str.09-259-0209-259-022026-05-29
04946329077605Bulldog Clamp 54 mm, L-Shaped.09-259-0309-259-032026-05-29
04946329077612Bulldog Clamp 67 mm, L Cvd.09-259-0409-259-042026-05-29
04946329077629Bulldog Clamp 57 mm, S Cvd.09-259-0509-259-052026-05-29
04946329150216Micro Scissors Streamline S, 175 mm Straight, Super Fine Tip07-814-0107-814-012026-05-29
04946329150223Micro Scissors Streamline S, 175 mm Curved, Super Fine Tip07-814-0207-814-022026-05-29
04946329150230Micro Scissors Streamline M, 190 mm Straight, Super Fine Tip07-814-0307-814-032026-05-29
04946329150247Micro Scissors Streamline M, 190 mm Curved, Super Fine Tip07-814-0407-814-042026-05-29
04946329150254Micro Scissors Streamline L, 220 mm Straight, Super Fine Tip07-814-0507-814-052026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04250603734031LAZICPeter Lazic GmbHHCH2025-06-16
04250603733980LAZICPeter Lazic GmbHHCH2025-05-13
04946329416725SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416732SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416749SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
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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
04946329389340Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04946329389357Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
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04946329389371Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04250603703686LAZICPeter Lazic GmbHHCH2023-07-13