FDA.reportPublic FDA data

Head rest standard

Primary DI
07640143932658
Brand
Head rest standard
Company
Schaerer Medical AG
Model
for Axis 400-700
Catalog number
91490
Published
2025-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GDCTable, Operating-Room, Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640143932658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640143932658076401439326587640143932658

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. It is available in various shapes and sizes and might include mechanisms to enable adjustments in relation to the table top. It does not include components intended for immobilization of the head (i.e., not a positioner). 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

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
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
07640143932412Schaerer Medical92410924102023-07-03
07640143933044Schaerer Medical91451914512023-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00728564070009Assist Powered Medical Exam TableThe Brewer Company LLCGDC2025-11-10
00728564075004Assist Powered Medical Exam TableThe Brewer Company LLCGDC2025-11-10
00810050245562NADOMICO MED-DEVICE, LLCGDC2025-09-24
00724995244880NASTERIS CORPORATIONGDC2025-05-05
00724995244965NASTERIS CORPORATIONGDC2025-05-05
00724995245030CMAX XRAY Remote ControlSTERIS CORPORATIONGDC2025-05-05
00887761966673Carbon Pelvic systemBaxter Medical Systems GmbH + Co. KGGDC2025-01-17
00857534006721Headboard AssemblyIMRIS Imaging, Inc.GDC2024-10-04
00887761967977Hillrom™Baxter Medical Systems GmbH + Co. KGGDC2024-02-22
00887761967984Hillrom™Baxter Medical Systems GmbH + Co. KGGDC2024-02-22
00887761967342Orthopedic ExtensionBaxter Medical Systems GmbH + Co. KGGDC2023-01-17
00887761967717Control UnitsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967731Back SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967748Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967762Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967793Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967809Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967816Back SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967823Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967830Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967847Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967854Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967861Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967878PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967892PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967908PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967922PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761968660Control UnitsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967526TS 7000Baxter Medical Systems GmbH + Co. KGGDC2022-12-27
00887761967533TS 7000Baxter Medical Systems GmbH + Co. KGGDC2022-12-27