FDA.reportPublic FDA data

Sugita AVM Microclip II

Primary DI
04946329389364
Brand
Sugita AVM Microclip II
Company
MIZUHO CORPORATION
Model
07-932-14
Catalog number
07-932-14
Device description
TYPE: PERMANENTRANGE: 50-70gf(0.49-0.69N)MATERIAL: ISO 5832-7/ASTM F1058G2BLADE: STRAIGHTMAXIMUM OPENING: 2.0mmGRIP SURFACE: SERRATED
Published
2023-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
04946329389364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04946329389364049463293893644946329389364

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
Length4Millimeter

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
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04946329039580Kerrison Rongeur 150 x 2 mm, 35 deg, Upward02-095-0102-095-012026-06-03
04946329039597Kerrison Rongeur 150 x 3 mm, 35 deg, Upward02-095-0202-095-022026-06-03
04946329039603Kerrison Rongeur 150 x 4 mm, 35 deg, Upward02-095-0302-095-032026-06-03
04946329039610Kerrison Rongeur 150 x 5 mm, 35 deg, Upward02-095-0402-095-042026-06-03
04946329039627Kerrison Rongeur 180 x 3 mm, 35 deg, Upward02-095-0502-095-052026-06-03
04946329039634Kerrison Rongeur 180 x 4 mm, 35 deg, Upward02-095-0602-095-062026-06-03
04946329039641Kerrison Rongeur 180 x 5 mm, 35 deg, Upward02-095-0702-095-072026-06-03
04946329039658Kerrison Rongeur 180 x 1 mm, 35 deg, Upward02-095-0802-095-082026-06-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250603703679LAZICPeter Lazic GmbHHCH2025-10-30
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04250603709527LAZICPeter Lazic GmbHHCH2025-08-07
04250603714835LAZICPeter Lazic GmbHHCH2025-08-07
04250603733911LAZICPeter Lazic GmbHHCH2025-08-07
04250603753018LAZICPeter Lazic GmbHHCH2025-06-30
04250603727194LAZICPeter Lazic GmbHHCH2025-06-16
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
04946329416756SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416763SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
G586N697205A0NovosurgicalNOVO SURGICAL, INC.HCH2025-02-06
G586N697206A0NovosurgicalNOVO SURGICAL, INC.HCH2025-02-06
G586N6971710NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
G586N6971730NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
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
04946329389371Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04250603703686LAZICPeter Lazic GmbHHCH2023-07-13