Home GUDID 00810105030303 Split Leg Positioner Pair with Pad
Primary DI 00810105030303
Brand Split Leg Positioner Pair with Pad
Company COMPOSITE MANUFACTURING, INC.
Model 1-1013-001
Device description Carbon fiber split leg positioner device which allows for mid-line access to the patient with controls to independently adjust the legs for full abduction/adduction as well as positioning to high lithotomy. Ideal for Laparoscopic and orthopaedic 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 00810105030303 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 00810105030303 00810105030303 810105030303 0810105030303
GMDN Terms# Term, Definition table Term Definition Leg procedure positioner A preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure). It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically 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 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 00810105030686 Skytron Spine Frame 3-090-01 2024-03-22
Other Devices Sharing Product Codes# 
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