FDA.report

Radiographic Tops Fixed Type

Primary DI
04946329318852
Brand
Radiographic Tops Fixed Type
Company
MIZUHO CORPORATION
Model
08-089-66
Catalog number
08-089-66
Device description
Digital X-Ray Top Set 3603
Published
2022-04-15
Public version status
New
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
GDCTable, Operating-Room, Electrical

Product Code Classifications

CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04946329318852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04946329318852049463293188524946329318852

GMDN Terms

TermDefinition
Universal operating table topA component of a modular operating table designed as a detachable table top that can be adjusted to support a patient during many types of surgical interventions. It may consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or intended to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have x-ray transparent features.

Device Sizes

TypeValueUnit
Length585Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
9999999999regulatory@mizuho.co.jp

Regulatory Flags

DUNS number
690677802
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04946329173932Operating Table VACB-3006B08-041-2008-041-202025-09-05
04946329308259Operating Table VACB-3006B Type150S08-055-7508-055-752025-09-05
04946329385847Narrow head section08-075-0008-075-002025-09-05
04946329385854Narrow head section08-083-6908-083-692025-09-05
04946329385861Narrow head section08-083-7008-083-702025-09-05
04946329404555Operating Table MST-7300BX18-045-1418-045-142025-09-05
04946329443066Side Rail Clamp (18 mm)08-110-1808-110-182025-06-26
04946329404234Short Boot Extender18-070-5018-070-502025-06-10
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
04946329416763SUGITA TITANIUM ANEURYSM CLIP II17-002-4417-002-442025-04-25
04946329385519Operating Table MOT-VS70018-042-1118-042-112024-11-06
04946329385526Operating Table MOT-VS70018-042-2218-042-222024-11-06
04946329385533Operating Table MOT-VS70018-042-2318-042-232024-11-06
04946329385564Operating Table MOT-VS70018-042-6118-042-612024-11-06
04946329385571Operating Table MOT-VS70018-042-5218-042-522024-11-06
04946329385588Operating Table MOT-5602BW18-042-5318-042-532024-11-06
04946329395310Operating Table MST-7300BX18-042-0218-042-022024-11-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00615521070069ALLENHILL-ROM, INC.GDC2026-02-27
00724995244972NASTERIS CORPORATIONGDC2026-02-13
06975678805018PAXShanghai PAX Medical Instrument Co., Ltd.GDC2026-02-13
04260647941494SC 5010 ESAKRUS GmbH & Co. KGGDC2025-11-28
04260647941500SC 5010 HSAKRUS GmbH & Co. KGGDC2025-11-28
04260647941579SB 5010 ESAKRUS GmbH & Co. KGGDC2025-11-28
04260647941586SB 5010 HSAKRUS GmbH & Co. KGGDC2025-11-28
04260647946321Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946338Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946345Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946376Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946383Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946390Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946406Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946420Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946437Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946444Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946451Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04946329173932Operating Table VACB-3006BMIZUHO CORPORATIONGDC2025-09-05
04946329308259Operating Table VACB-3006B Type150SMIZUHO CORPORATIONGDC2025-09-05
04946329385847Narrow head sectionMIZUHO CORPORATIONGDC2025-09-05
04946329385854Narrow head sectionMIZUHO CORPORATIONGDC2025-09-05
04946329385861Narrow head sectionMIZUHO CORPORATIONGDC2025-09-05
04946329404555Operating Table MST-7300BXMIZUHO CORPORATIONGDC2025-09-05
07640143930043Intermediate plate Schaerer Medical AGGDC2025-07-23
07640143930050Intermediate plateSchaerer Medical AGGDC2025-07-23
07640143930166Side rail adapterSchaerer Medical AGGDC2025-07-23
07640143930180Side rail adapterSchaerer Medical AGGDC2025-07-23
07640143930807Side rail (1 pcs.)Schaerer Medical AGGDC2025-07-23
07640143930852Leg plates 2-part Schaerer Medical AGGDC2025-07-23