FDA.report

Radiolucent Head Frame

Primary DI
04946329355482
Brand
Radiolucent Head Frame
Company
MIZUHO CORPORATION
Model
07-952-08
Catalog number
07-952-08
Device description
Head Arm Base, Pin dia. 16mm
Published
2019-10-23
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
HBLHolder, Head, Neurosurgical (Skull Clamp)

Product Code Classifications

CodeDeviceSpecialtyClass
HBLHolder, Head, Neurosurgical (Skull Clamp)Neurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04946329355482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04946329355482049463293554824946329355482

GMDN Terms

TermDefinition
Skull clampA U-shaped surgical device intended to hold the head and neck in a particular fixed position during surgical procedures. It is connected to the skull with screws or pins (not included), typically on each side of the forehead, whilst the other end is fixed to an operating table or chair. Commonly known as a Mayfield skull clamp, it is made of metal materials (non-radiolucent) and may have adjustable joints to allow variable head positioning; it is not intended for applying traction forces to the cervical spine. This is a reusable device.

Device Sizes

TypeValueUnit
Length540Millimeter

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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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
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04946329385526Operating Table MOT-VS70018-042-2218-042-222024-11-06
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04946329385564Operating Table MOT-VS70018-042-6118-042-612024-11-06
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