FDA.reportPublic FDA data

Schaerer Medical

Primary DI
07640143932412
Brand
Schaerer Medical
Company
Schaerer Medical AG
Model
92410
Catalog number
92410
Device description
Head rest standard for schaerer® arcus
Published
2023-07-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640143932412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640143932412076401439324127640143932412

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 available in various shapes and sizes and might 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
484713792
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
07640143930043Intermediate plate for Axis909512025-07-23
07640143930050Intermediate platefor Axis909522025-07-23
07640143930166Side rail adapterShort916032025-07-23
07640143930180Side rail adapterLong916042025-07-23
07640143930807Side rail (1 pcs.)for Axis905932025-07-23
07640143930852Leg plates 2-part for Axis 400-700914952025-07-23
07640143932658Head rest standard for Axis 400-700914902025-07-23
07640143930029Axis700915972025-06-18
07640143930296Hand surgery table with fixing screw909132025-06-18
07640143930487Carbon spine frameCSF916002025-06-18
07640143930005Axis500915952025-05-08
07640143930012Axis600915962025-05-08
07640143930135Carbon-fibre plate850mm906242025-05-08
07640143930173Carbon fibre-plate850mm906252025-05-08
07640143930654Carbon-fibre plate1400mm906272025-05-08
07640143930906Radial setting clampwith fixing screw905062025-05-08
07640143932450Infusion Polewith fixing clamp905002025-05-08
07640143932610Anaesthesia screenrigid903212025-05-08
07640143930708Schaerer Medical90913909132023-07-03
07640143933044Schaerer Medical91451914512023-07-03

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