Home GUDID 00810105030686 Skytron Spine Frame
Primary DI 00810105030686
Brand Skytron Spine Frame
Company COMPOSITE MANUFACTURING, INC.
Model 3-090-01
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 2024-03-22
Public version status New
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 00810105030686 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 00810105030686 00810105030686 810105030686 0810105030686
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
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