Home GUDID 00810105030297 Tenzor Radiolucent Carbon Fiber Spine Positioning Frame
Primary DI 00810105030297
Brand Tenzor Radiolucent Carbon Fiber Spine Positioning Frame
Company COMPOSITE MANUFACTURING, INC.
Model 4-0009-001
Device description Radiolucent Spine positioning traction frame. Arcing flexures are used to arc the patients spine while in the prone position to expose the spine for surgical procedures.
Published 2020-02-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name BWN Table And Attachments, Operating-Room
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BWN Table And Attachments, Operating-Room General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810105030297 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 00810105030297 00810105030297 810105030297 0810105030297
GMDN Terms# Term, Definition table Term Definition Traction table, manual A mobile, manually-operated, table designed to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a mechanical altering of the table surface geometry. The surface typically consists of sections that can be raised and lowered to manipulate the curvature of the patient?s spine whilst he/she lies in a supine position. Interchangeable traction devices such as head halters, pelvic belts, traction boots, and a traction unit may be used with this table. It is typically used in a healthcare facility.
Regulatory Flags# DUNS number 947090650 Device count 1 Premarket exempt true Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810105030785 "55"" Imaging Extension, Kit" 3-2005-009 OZ 7567775 2025-03-03 00810105030631 Skytron Split Leg 4-030-70 2024-03-22 00810105030648 "Skytron Split Leg Pad Set 2""" 4-030-70-2S 2024-03-22 00810105030655 "Skytron Split Leg Pad Set 3""" 4-030-70-3S 2024-03-22 00810105030662 "Skytron Split Leg Pad Set 4""" 4-030-70-4S 2024-03-22 00810105030679 "Skytron Split Leg Pad Set 5""" 4-030-70-5S 2024-03-22 00810105030006 Orthopedic Fracture Attachment Kit, Berchtold 3-1000-001 OZ 7531775 2021-06-14 00810105030013 Euro Orthopedic Fracture Attachment 3-2006-001 OZ 7531704 2020-03-24 00810105030303 Split Leg Positioner Pair with Pad 1-1013-001 2020-02-14 00810105030754 Adult Arm and Hand Table, No Pad 1-1014-005 2024-05-13 00810105030761 Pediatric Arm and Hand Table No Pad 1-1015-005 2024-05-13 00810105030778 Microsurgical Arm and Hand Table No Pad 1-1016-005 2024-05-13 00810105030730 CMI Spine Frame Head Foam Supports (12 Pack) 4-0009-203 2024-04-25 00810105030747 CMI Spine Frame Arm Covers (12 Pack) 4-0009-204 2024-04-25 00810105030723 Multi Posture Armboard Kit 1-1024-001 2024-04-03 00810105030587 Trigger Lite Armboard 2-010-10 2024-03-22 00810105030594 "Trigger Lite Armboard Pad 2""" 2-010-10-2WS 2024-03-22 00810105030600 "Trigger Lite Armboard Pad 3""" 2-010-10-3WS 2024-03-22 00810105030617 "Trigger Lite Armboard Pad 4""" 2-010-10-4WS 2024-03-22 00810105030624 "Trigger Lite Armboard Pad 5""" 2-010-10-5WS 2024-03-22
Other Devices Sharing Product Codes# 
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