FDA.reportPublic FDA data

"Voss 9"" Round Support"

Primary DI
00811304020539
Brand
"Voss 9"" Round Support"
Company
VM/POSITIONING, INC.
Model
714-9RS
Device description
"9"" disposable foam round head support"
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
EPWSupport, Head, Surgical, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPWSupport, Head, Surgical, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811304020539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811304020539008113040205398113040205390811304020539

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
Length9Inch

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
00811304020546Voss Medium Body Wedge714-MBW2018-06-11
00811304020560"Voss Chest Roll 5"" x 17"""714-CR2018-06-11
00811304020584Voss Adult Supine Head Rest714-AHR2018-06-11
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
04250381851463Forceps holderSpiggle & Theis Medizintechnik GmbHEPW2025-09-25
04250381862520Solution bowlSpiggle & Theis Medizintechnik GmbHEPW2025-09-19
04250676740007Solution bowlSpiggle & Theis Medizintechnik GmbHEPW2025-09-19
04250676740014Solution bowlSpiggle & Theis Medizintechnik GmbHEPW2025-09-19
04250676740021Metal cupSpiggle & Theis Medizintechnik GmbHEPW2025-09-19
00810075280999Bone FoamBONE FOAM, INC.EPW2022-05-22
00810075281002Bone FoamBONE FOAM, INC.EPW2022-05-22
00810075280104BoneFoamBONE FOAM, INC.EPW2022-05-22
20681490013240N/AMEDTRONIC XOMED, INC.EPW2021-07-04
00681490039017Bio-FlekMEDTRONIC XOMED, INC.EPW2021-07-04
00681490039024Bio-FlekMEDTRONIC XOMED, INC.EPW2021-07-04
00681490013246N/AMEDTRONIC XOMED, INC.EPW2021-07-04
00763000299101Bio-FlekMEDTRONIC XOMED, INC.EPW2021-04-25
00763000299118Bio-FlekMEDTRONIC XOMED, INC.EPW2021-04-25
00821925037731GYRUS ACMI Gyrus ACMI, LLCEPW2015-10-24