DEVICE: Multipurpose Head Frame (04946329135534)

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Device Identifier (DI) Information

Multipurpose Head Frame
07-951-11
07-951-11
MIZUHO CORPORATION
04946329135534
GS1
1
Smart Fix C Holder
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Skull clamp A U-shaped surgical device that is attached to the skull to hold the head and neck in a particular fixed position during surgical procedures. Pointed screws are extended from this device and screwed into the patient's skull, typically one on either side of the forehead whilst the other end is fixed to an operating table or chair where the patient is correctly positioned. It is commonly known as a Mayfield skull clamp, and typical applications include neurosurgical procedures. It is made of metal materials (non-radiolucent) with adjustable joints to allow variable head positioning and is generally not intended for applying traction forces to the cervical spine. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
HBL Holder, Head, Neurosurgical (Skull Clamp)
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 290.0 Millimeter
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Device Status

In Commercial Distribution
September 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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800 699 2547
mizuho@mizuho.com
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