Home GUDID 00810105030198
"Bariatric Table Extension, Full Set of 8 with 2"" Pads, 20"" Leg Section"
Primary DI 00810105030198
Brand "Bariatric Table Extension, Full Set of 8 with 2"" Pads, 20"" Leg Section"
Company COMPOSITE MANUFACTURING, INC.
Model 3-2001-002
Catalog number OZ 7556975
Device description Modular, radioluscent carbon fiber surgical table width extenders for accommodating bariatric patients.
Published 2022-08-16
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 00810105030198 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 00810105030198 00810105030198 810105030198 0810105030198
GMDN Terms# Term, Definition table Term Definition Operating table patient positioning set, reusable A collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). 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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