FDA.reportPublic FDA data

"Voss 7"" Round Support"

Primary DI
00811304020522
Brand
"Voss 7"" Round Support"
Company
VM/POSITIONING, INC.
Model
714-7RS
Device description
"7"" 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
PRNPediatric Position Holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRNPediatric Position HolderGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811304020522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811304020522008113040205228113040205220811304020522

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
Length7Inch

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
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
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
20888277668000MEDLINEMEDLINE INDUSTRIES, INC.PRN2025-02-13
10888277668003MEDLINEMEDLINE INDUSTRIES, INC.PRN2025-02-13
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04260764840571MedibinoNEO ring – TG PUR Gel - Size S - PU6Kluba Medical GmbHPRN2024-09-06
04260764840649MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50Kluba Medical GmbHPRN2024-09-06
04260764840656MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
04260764840663MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50Kluba Medical GmbHPRN2024-09-06
04260764840670MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50Kluba Medical GmbHPRN2024-09-06
04260764840687MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
04260764840694MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50Kluba Medical GmbHPRN2024-09-06
04260764840564MedibinoNEO ring – TG PUR Gel - Size M - PU6Kluba Medical GmbHPRN2024-09-06
04260764840823MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50Kluba Medical GmbHPRN2024-09-06
04260764840830MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
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10810087351240CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351349CoulmedCoulmed Products Group LLCPRN2023-01-06
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10810087351707CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351714CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351721CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351899CoulmedCoulmed Products Group LLCPRN2023-01-06