FDA.reportPublic FDA data

SUGITA ANEURYSM CLIP

Primary DI
04946329061192
Brand
SUGITA ANEURYSM CLIP
Company
MIZUHO CORPORATION
Model
07-940-54
Catalog number
07-940-54
Device description
TYPE: TEMPORARY STD, TEMPORARY, No.54RANGE: 55-75gf(0.54-0.74N)MATERIAL: ISO 5832-7/ASTM F1058G2BLADE: BENTMAXIMUM OPENING: 4.5mmGRIP 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
HCIApplier, Aneurysm Clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCIApplier, Aneurysm ClipNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04946329061192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04946329061192049463290611924946329061192

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
Length8Millimeter

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
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
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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
04046955823352AESCULAPAESCULAP, INC.HCI2023-01-24
04250603747239LAZICPeter Lazic GmbHHCI2022-12-13
04046964725470NOIRAesculap AGHCI2022-05-06
04046964725487NOIRAesculap AGHCI2022-05-06
04046964725494NOIRAesculap AGHCI2022-05-06
04046964725791NOIRAesculap AGHCI2022-05-06
04046964725807NOIRAesculap AGHCI2022-05-06