FDA.reportPublic FDA data

Radiolucent Head Frame Basic Set

Primary DI
04946329375275
Brand
Radiolucent Head Frame Basic Set
Company
MIZUHO CORPORATION
Model
07-986-60
Catalog number
07-986-60
Device description
Radiolucent Head Frame Basic Set
Published
2021-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBLHolder, Head, Neurosurgical (Skull Clamp)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBLHolder, Head, Neurosurgical (Skull Clamp)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04946329375275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04946329375275049463293752754946329375275

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999regulatory@mizuho.co.jp

Regulatory Flags#

DUNS number
690677802
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04946329039580Kerrison Rongeur 150 x 2 mm, 35 deg, Upward02-095-0102-095-012026-06-03
04946329039597Kerrison Rongeur 150 x 3 mm, 35 deg, Upward02-095-0202-095-022026-06-03
04946329039603Kerrison Rongeur 150 x 4 mm, 35 deg, Upward02-095-0302-095-032026-06-03
04946329039610Kerrison Rongeur 150 x 5 mm, 35 deg, Upward02-095-0402-095-042026-06-03
04946329039627Kerrison Rongeur 180 x 3 mm, 35 deg, Upward02-095-0502-095-052026-06-03
04946329039634Kerrison Rongeur 180 x 4 mm, 35 deg, Upward02-095-0602-095-062026-06-03
04946329039641Kerrison Rongeur 180 x 5 mm, 35 deg, Upward02-095-0702-095-072026-06-03
04946329039658Kerrison Rongeur 180 x 1 mm, 35 deg, Upward02-095-0802-095-082026-06-03
04946329056440CEA Scissors 170 mm, 35 deg. Downward Cvd07-501-0107-501-012026-05-29
04946329056457CEA Scissors 180 mm, Sideward Cvd.07-501-0207-501-022026-05-29
04946329056464CEA Micro Scissors 170 mm, 35 deg. Downward Cvd.07-501-0307-501-032026-05-29
04946329056471CEA Thin Needle Holder 170 mm07-501-1107-501-112026-05-29
04946329056488CEA Micro Forceps 180 mm, Cvd.07-501-2107-501-212026-05-29
04946329056495CEA Micro Forceps 180 mm, L Str.07-501-2207-501-222026-05-29
04946329056501CEA Micro Forceps 150 mm, S Str.07-501-2307-501-232026-05-29
04946329058802Yasargil micro raspatory, curved, 18.5 cm07-839-0007-839-002026-05-29
04946329058987Micro Scissors 130 mm, FH07-862-0007-862-002026-05-29
04946329077476Pediatric Mosquito Applier without Hook Str09-230-0309-230-032026-05-29
04946329077582Bulldog Clamp 82 mm, L Str.09-259-0109-259-012026-05-29
04946329077599Bulldog Clamp 67 mm, S Str.09-259-0209-259-022026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780253716MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256113MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256120MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256137MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256144MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256151MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256175MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256182MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256199MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256205MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256212MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256229MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256236MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256243MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256250MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256267MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256274MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256281MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256687MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780025757MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025764MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025771MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025788MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025795MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025818MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253334MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253341MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253358MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253365MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253372MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26