FDA.reportPublic FDA data

SUGITA TITANIUM ANEURYSM CLIP II

Primary DI
04946329138443
Brand
SUGITA TITANIUM ANEURYSM CLIP II
Company
MIZUHO CORPORATION
Model
17-001-45
Catalog number
17-001-45
Device description
TYPE: FENESTRATED, PERMANENT, No.45 RANGE: 139-161gf(1.36-1.58N) MATERIAL: ISO 5832-3/ASTM F136, ISO 5832-2/ASTM F1341G2 BLADE: BAYONET MAXIMUM OPENIN
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

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
04946329138443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04946329138443049463291384434946329138443

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
Length7.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800 699 2547mizuho@mizuho.com
9999999999regulatory@mizuho.co.jp

Regulatory Flags#

DUNS number
690677802
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DI, Brand, Model table
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

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Primary DI, Brand, Company table
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