FDA.report

Fukushima Keyhole Clip Applier

Primary DI
04946329190366
Brand
Fukushima Keyhole Clip Applier
Company
MIZUHO CORPORATION
Model
17-015-02
Catalog number
17-015-02
Device description
Fukushima Keyhole Clip Applier for Sugita Titanium Clip II Standard 5 degree Angled Up
Published
2015-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HCIApplier, Aneurysm Clip

Product Code Classifications

CodeDeviceSpecialtyClass
HCIApplier, Aneurysm ClipNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04946329190366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04946329190366049463291903664946329190366

GMDN Terms

TermDefinition
Aneurysm clip applierA surgical instrument designed for the application/insertion of aneurysm clips (devices for approximating the edges of the neck of an aneurysm or for the prevention of bleeding from small individual blood vessels). This is a reusable device.

Device Sizes

TypeValueUnit
Length218Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
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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04946329416732SUGITA TITANIUM ANEURYSM CLIP II17-002-4117-002-412025-04-25
04946329416749SUGITA TITANIUM ANEURYSM CLIP II17-002-4217-002-422025-04-25
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