FDA.reportPublic FDA data

Voss Cervical Laminectomy Harness

Primary DI
00811304020140
Brand
Voss Cervical Laminectomy Harness
Company
VM/POSITIONING, INC.
Model
CLH-58K
Device description
Voss CLH Kit is is used for shoulder retraction.
Published
2018-01-31
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
IQFOrthosis, Cervical-Thoracic, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQFOrthosis, Cervical-Thoracic, RigidPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811304020140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811304020140008113040201408113040201400811304020140

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck immobilizer, single-useA rigid or non-rigid, non-sterile, device usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
00645517888613TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517890883TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517898940TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517899114TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517024189TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323831TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323848TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323886TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323947TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517510729TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517510743TrulifeTRULIFE LIMITEDIQF2025-09-03
08057592700094NECKLITEFLAMOR SRLIQF2025-01-27
08057592700100NECKLITEFLAMOR SRLIQF2025-01-27
08057592700117NECKLITEFLAMOR SRLIQF2025-01-27
08057592700124NECKLITEFLAMOR SRLIQF2025-01-27
08057592700131NECKLITEFLAMOR SRLIQF2025-01-27
08057592700148NECKLITEFLAMOR SRLIQF2025-01-27
00645517024172TrulifeTRULIFE LIMITEDIQF2023-06-06
00645517322674TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517322681TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517322698TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517325002TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517326306TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517326351TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517326375TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517317991TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318004TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318011TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318028TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318035TrulifeTRULIFE LIMITEDIQF2022-12-31