Smart Fix Basic Set 07-982-02

GUDID 04946329375268

Smart Fix Basic Set

MIZUHO CORPORATION

Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp
Primary Device ID04946329375268
NIH Device Record Keyfaa2ecc6-4a1d-48e6-98c1-4c9986d09269
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart Fix Basic Set
Version Model Number07-982-02
Catalog Number07-982-02
Company DUNS690677802
Company NameMIZUHO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9999999999
Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp
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Emailregulatory@mizuho.co.jp

Device Identifiers

Device Issuing AgencyDevice ID
GS104946329375268 [Primary]

FDA Product Code

HBLHolder, Head, Neurosurgical (Skull Clamp)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


[04946329375268]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

Devices Manufactured by MIZUHO CORPORATION

04946329404715 - NIBS-Es Malleable Instruments Tray2024-03-11 NIBS-Es Malleable Instruments Tray
04946329397734 - Sugita AVM Microclip II Single Shaft Applier2024-01-05 Sugita AVM Microclip II Single Shaft Applier 90 mm, Str, w/o Catches
04946329397741 - Sugita AVM Microclip II Single Shaft Applier2024-01-05 Sugita AVM Microclip II Single Shaft Applier 90 mm, 30 deg, w/o Catches
04946329397758 - Sugita AVM Microclip II Single Shaft Applier2024-01-05 Sugita AVM Microclip II Single Shaft Applier 110 mm, Str, w/o Catches
04946329397765 - Sugita AVM Microclip II Single Shaft Applier2024-01-05 Sugita AVM Microclip II Single Shaft Applier 110 mm, 30 deg, w/o Catches
04946329397772 - Sugita AVM Microclip II Single Shaft Applier2024-01-05 Sugita AVM Microclip II Single Shaft Applier 150 mm, Str, w/o Catches
04946329397789 - Sugita AVM Microclip II Single Shaft Applier2024-01-05 Sugita AVM Microclip II Single Shaft Applier 150 mm, 30 deg, w/o Catches
04946329389340 - Sugita AVM Microclip II2023-12-27 TYPE: PERMANENT RANGE: 50-70gf(0.49-0.69N) MATERIAL: ISO 5832-7/ASTM F1058G2 BLADE: STRAIGHT MAXIMUM OPENING: 1.5mm GRIP SURFACE

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