Profile-ESP Bolster

Primary DI
00868579000261
Brand
Profile-ESP Bolster
Company
ORTHO KINEMATICS, INC.
Model
3.0
Device description
The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending.The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg).
Published
2019-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
INWTable, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INWTable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868579000261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868579000261008685790002618685790002610868579000261

GMDN Terms#

Term, Definition table
TermDefinition
Basic diagnostic x-ray system table, non-poweredA non-powered table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
932053221
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868579000216VMA DataLink Software2.32016-09-22
00868579000223VMA DataLink Software32017-12-12
00868579000230VMA Image Acquisition Software32017-12-12
00868579000278Profile-ESP Radiographic marker3.02019-02-14
00868579000209VMA22016-09-22
00868579000247VMA Motion Normalizer32018-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06972077026570PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026594SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026600SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026617SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026624SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026631CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026648CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026655JOYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026662JOYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
00815235022617UMF MedicalUNITED METAL FABRICATORS, INC.INW2026-05-14
06972077026433ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026440ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026549ProactiveXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026556PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026259EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026280EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
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06972077026303EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026761EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026778EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026174CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026181CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026211CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026310ProactiveXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
05715393022809R82R82 A/SINW2026-01-20
05715393022816R82R82 A/SINW2026-01-20
05715393022823R82R82 A/SINW2026-01-20
05715393022830R82R82 A/SINW2026-01-20