FDA.report

Standard Armboard

Primary DI
04946329067484
Brand
Standard Armboard
Company
MIZUHO CORPORATION
Model
08-065-08
Catalog number
08-065-08
Device description
40 mm Pad for Armboard
Published
2022-06-16
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
04946329067484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04946329067484049463290674844946329067484

GMDN Terms

TermDefinition
Operating table mattress, basicA foam-filled cushion designed as a component of an operating table to serve as the surface upon which the patient is placed. It is typically filled with high-density polyurethane or a memory foam, and may be an integral part of the table (i.e., removable only with tools) or loosely fitted to the table top (e.g., by way of press studs, Velcro strips, or eyeholes and pegs) and is removable for cleaning. The device is firm, waterproof, and washable using strong disinfectants. It is available as one full-length piece or in sections. This is a reusable device.

Device Sizes

TypeValueUnit
Length500Millimeter

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

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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

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