Surgical C Arm Table

Basic Information

• Brand Name: Surgical C Arm Table
• Primary DI: 00718175000090
• Version / Model: 056-025
• Catalog Number: 056-025
• Company Name: BIODEX MEDICAL SYSTEMS, INC.
• Labeler DUNS: 043833813
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-18
• Public Version: 3
• Public Version Date: 2023-07-25
• Public Version Status: Update
• Public Device Record Key: 26f88fb6-96cf-4e04-972c-8e317231db53
• Distribution End Date: 2023-07-24

Device Description

Table, Surgical C-Arm, Fixed Height

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXJ	Table, Radiologic	Radiology	892.1980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40657	Fluoroscopy/angiography table, non-powered	A non-electric table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with either a fixed position or mechanical table top positional controls (e.g., lever mechanism). It is not dedicated to breast biopsy, and not designed for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00718175000090	GS1