FDA.report

SUGITA TITANIUM ANEURYSM CLIP

Primary DI
04946329059632
Brand
SUGITA TITANIUM ANEURYSM CLIP
Company
MIZUHO CORPORATION
Model
07-934-02
Catalog number
07-934-02
Device description
TYPE: STANDARD, PERMANENT, No.2 RANGE: 130-165gf(1.27-1.62N) MATERIAL: ISO 5832-3/ASTM F136, ISO 5832-2/ASTM F1341G2 BLADE: STRAIGHT MAXIMUM OPENING: 8.0mm GRIP SURFACE: SERRATED
Published
2015-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HCHClip, Aneurysm

Product Code Classifications

CodeDeviceSpecialtyClass
HCHClip, AneurysmNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04946329059632PrimaryGS10

GMDN Terms

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

TypeValueUnit
Length10Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800 699 2547mizuho@mizuho.com
9999999999regulatory@mizuho.co.jp

Regulatory Flags

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

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