FDA.reportPublic FDA data

Horseshoe Headrest

Primary DI
00857534006837
Brand
Horseshoe Headrest
Company
IMRIS Imaging, Inc.
Model
116668-000
Device description
Horseshoe Headrest Starter Kit, HFD 100
Published
2024-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
HBMHeadrest, Neurosurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBMHeadrest, NeurosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857534006837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857534006837008575340068378575340068370857534006837

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding headrest, reusableA device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attached to a parent device. The headrest is typically made of shock-absorbing materials (e.g., memory foam, gel) that cushion the head and is available in various sizes and shapes including head pad, head ring, and concave ergonomic holders with fingered lateral supports to position the head. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079990922
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
00850085914002IMRISeyeP1225062026-05-07
00857534006318Horseshoe HeadrestHorseshoe Headrest HFD100 Assembly2016-10-01
00857534006325Horseshoe HeadrestHorseshoe Headrest HFD200 Assembly2016-10-01
00857534006929Neuro II-SE105000-00X2026-03-20
00857534006110iMRX SystemAnt Assy, 1.5T 16CH Cardiac Coil2016-09-23
00857534006127iMRX SystemPOSTERIOR ASSY, 3T 16CH CARDIAC COIL2016-09-23
00857534006141iMRX SystemANTERIOR ASSY, 3T 16CH CARDIAC COIL2016-11-04
00857534006158iMRX SystemPost Assy, 1.5T 16CH Cardiac Coil2016-11-04
00857534006165iMRX SystemiMRX System AR-DR-OR2016-11-04
00857534006172iMRX SystemiMRX System AR-DR-AR2016-09-23
00857534006189iMRX SystemiMRX System AR-DR MR30RS2016-09-23
00857534006851InVision™ 3T Recharge Operating SuiteP1221812025-09-18
00857534006868IMRISmatrix 5.0P1223092025-09-18
00857534006875IMRISmatrix 5.0P1223102025-09-18
00857534006370InSitu Coil, 3TInSitu Coil, Open 3T2016-11-23
00857534006714Patient Support Board119749-0002020-09-18
00857534006844Horseshoe Headrest116961-0002024-11-01
00857534006271VISIUSeye117532-0002024-10-04
00857534006295VISIUSeye117533-0002024-10-04
00857534006301VISIUSeye117535-0002024-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995244996NASTERIS CORPORATIONHBM2025-05-05
00724995244910NASTERIS CORPORATIONHBM2025-05-05
04250435529867DORO LUCENT® iMRI Transfer Collision Indicator Black Forest Medical GmbHHBM2025-02-10
00850068304172SBHSBH SurgicalHBM2024-12-06
00850068304158SBHSBH SurgicalHBM2024-12-03
00850068304165SBHSBH SurgicalHBM2024-12-03
00850068304189SBHSBH SurgicalHBM2024-12-03
00850068304196SBHSBH SurgicalHBM2024-12-03
00724995229290NASTERIS CORPORATIONHBM2024-11-25
00857534006844Horseshoe HeadrestIMRIS Imaging, Inc.HBM2024-11-01
04251554151502Reinforcement-Armmedical bees GmbHHBM2024-10-14
04250435501320DORO® Extensionbar Horseshoe Black Forest Medical GmbHHBM2024-07-11
00724995229160NASTERIS CORPORATIONHBM2024-03-08
00724995229177NASTERIS CORPORATIONHBM2024-03-08
00724995229184NASTERIS CORPORATIONHBM2024-03-08
00724995229191NASTERIS CORPORATIONHBM2024-03-08
00724995229207NASTERIS CORPORATIONHBM2024-03-08
00724995229214NASTERIS CORPORATIONHBM2024-03-08
00724995177782NASTERISHBM2023-12-11
04250435539378DORO® LUCENT iMRI Coil Connector IMRISBlack Forest Medical GmbHHBM2023-10-25
04250435539521DORO® LUCENT iMRI Interface Adaptor IMRISBlack Forest Medical GmbHHBM2023-10-25
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00883475954678Vertical Post TiltedCHARMANT INC.HBM2023-09-18
00883475954685Vertical Post UprightCHARMANT INC.HBM2023-09-18
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