FDA.reportPublic FDA data

Side rail modification kit

Primary DI
04046768029422
Brand
Side rail modification kit
Company
MAQUET GmbH
Model
100514B0
Published
2022-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BWNTABLE AND ATTACHMENTS, OPERATING-ROOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046768029422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046768029422040467680294224046768029422

GMDN Terms#

Term, Definition table
TermDefinition
Operating/examination/treatment table headrest, reusableA device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. This is a general-purpose headrest typically made of metal and synthetic materials that incorporate a cushion or pad that provides a softer surface for the patient's head to rest upon. It is available in various shapes and sizes and will typically include mechanical mechanisms to enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315435859
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053275000011GETINGE6710GSS67N Model 67102019-02-06
04053275000028GETINGE 6713GSS67N Model 67132019-02-06
04053275000035GETINGE6717GSS67N Model 67172019-02-06
04046768146600Traction Adapter100372AC2025-11-30
04046768151468Connection Bracket100405A02025-11-30
04046768151475Connection Bracket100405F02025-11-30
04046768151567Traction bar with ball for 1160 and 7700100740B02025-11-30
04046768151574Traction bar for 1160 and 7700100741B02025-11-30
04046768112704Disposable cover100729A02025-06-17
04046768148321Retrofit kit head fixation I116036A02024-11-21
04046768151208Retrofit kit head fixation II116036B02024-11-21
04046768000094Connection bracket100208002022-09-22
04046768000124Connector100258002022-09-22
04046768000421Cross-bar attachment100523002022-09-22
04046768000452Support arm100558002022-09-22
04046768001510Head rest adapter100207A02022-09-22
04046768001657Fixture100265A02022-09-22
04046768001688Horseshoe head rest100272A02022-09-22
04046768001695Flat head rest100273A02022-09-22
04046768001701Motorised head rest adjustment100274A02022-09-22

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