FDA.reportPublic FDA data

Voss Adult Supine Head Rest

Primary DI
00811304020584
Brand
Voss Adult Supine Head Rest
Company
VM/POSITIONING, INC.
Model
714-AHR
Device description
"disposable foam supine head rest 5"" x 10"" x 9.5"""
Published
2018-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
00811304020584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811304020584008113040205848113040205840811304020584

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023574260
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811304020140Voss Cervical Laminectomy HarnessCLH-58K2018-01-31
00811304020553Voss Laminectomy Harness714-LAC2018-06-11
00811304020577Voss Convoluted Arm Board714-CAB2018-06-11
00811304020102Voss PronePositionerP-39012018-01-31
00811304020126Voss Supine Positioner SN-10222018-06-11
00811304020522"Voss 7"" Round Support"714-7RS2018-06-11
00811304020539"Voss 9"" Round Support"714-9RS2018-06-11
00811304020546Voss Medium Body Wedge714-MBW2018-06-11
00811304020560"Voss Chest Roll 5"" x 17"""714-CR2018-06-11
00811304020591Voss Small Bolster714-SB2018-06-11
00811304020119Voss Cardiac Leg SupportL-39022018-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850068304172SBHSBH SurgicalHBM2024-12-06
00850068304158SBHSBH SurgicalHBM2024-12-03
00850068304165SBHSBH SurgicalHBM2024-12-03
00850068304189SBHSBH SurgicalHBM2024-12-03
00850068304196SBHSBH SurgicalHBM2024-12-03
00724995229290NASTERIS CORPORATIONHBM2024-11-25
00857534006837Horseshoe HeadrestIMRIS Imaging, Inc.HBM2024-11-01
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
00883475951172Fukushima Universal Holding SystemCHARMANT INC.HBM2023-09-18
00883475954623Mini C ClampCHARMANT INC.HBM2023-09-18
00883475954630Table ClampCHARMANT INC.HBM2023-09-18
00883475954647Tightening DriverCHARMANT INC.HBM2023-09-18
00883475954654U-Bar DistalCHARMANT INC.HBM2023-09-18
00883475954661U-Bar ProximalCHARMANT INC.HBM2023-09-18
00883475954678Vertical Post TiltedCHARMANT INC.HBM2023-09-18
00883475954685Vertical Post UprightCHARMANT INC.HBM2023-09-18