FDA.reportPublic FDA data

Spatula

Primary DI
04946329389852
Brand
Spatula
Company
MIZUHO CORPORATION
Model
07-959-03
Catalog number
07-959-03
Device description
Spatula 2 mm Stainless
Published
2023-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAOInstrument, Surgical, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04946329389852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04946329389852049463293898524946329389852

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical retraction system, brainA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism dedicated to the temporary parting of brain tissue during neurosurgery. It includes a mounting frame, mountable retracting blades, and may be intended to attach to a skull clamp (not included). It is typically made of high-grade stainless steel and synthetic polymer materials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length200Millimeter

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
Premarket exempt
true
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

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00810220800508Adler Instrument CompanyAdler, Inc.HAO2026-07-30
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