Home GUDID 00810105030273 Trenstop
Primary DI 00810105030273
Brand Trenstop
Company COMPOSITE MANUFACTURING, INC.
Model 1-1002-001
Device description Carbon Fiber Trendelenburg restraint table accessory. Designed for preventing patient movement while using the Trendelenburg position for surgical procedures. Device is attached to the operating table's side rails via accessory clamps.
Published 2020-02-13
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 00810105030273 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 00810105030273 00810105030273 810105030273 0810105030273
GMDN Terms# Term, Definition table Term Definition Torso intraoperative positioner A preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). It is typically used when the patient is in the prone or lateral position; components for attachment to the operating table (e.g., adaptors, straps) may be included. This is a reusable device.
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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