Home GUDID 00868579000261
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 Code Name INW Table, Mechanical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class INW Table, Mechanical Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00868579000261 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00868579000261 00868579000261 868579000261 0868579000261
GMDN Terms# Term, Definition table Term Definition Basic diagnostic x-ray system table, non-powered A 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.
Regulatory Flags# DUNS number 932053221 Device count 1 Premarket exempt true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06972077026532 PROHEAL XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-15 06972077026563 PROHEAL XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-15 06972077026570 PROHEAL XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-15 06972077026594 SPECIALTY XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-15 06972077026600 SPECIALTY XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-15 06972077026617 SPECIALTY XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-15 06972077026624 SPECIALTY XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-15 06972077026631 Costcare XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-15 06972077026648 Costcare XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-15 06972077026655 JOY XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-15 06972077026662 JOY XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-15 00815235022617 UMF Medical UNITED METAL FABRICATORS, INC. INW 2026-05-14 06972077026433 ALLICARE XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-07 06972077026440 ALLICARE XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-07 06972077026549 Proactive XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-07 06972077026556 PROHEAL XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-07 06972077026259 Emerald XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-06 06972077026280 Emerald XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-06 06972077026297 Emerald XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-06 06972077026303 Emerald XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-06 06972077026761 Emerald XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-06 06972077026778 Emerald XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-05-06 06972077026174 Costcare XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-04-24 06972077026181 Costcare XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-04-24 06972077026211 Costcare XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-04-24 06972077026310 Proactive XIAMEN TAFT MEDICAL CO.,LTD. INW 2026-04-24 05715393022809 R82 R82 A/S INW 2026-01-20 05715393022816 R82 R82 A/S INW 2026-01-20 05715393022823 R82 R82 A/S INW 2026-01-20 05715393022830 R82 R82 A/S INW 2026-01-20