X-ray top

Basic Information

• Brand Name: X-ray top
• Primary DI: 04046768002890
• Version / Model: 113280A0
• Company Name: MAQUET GmbH
• Labeler DUNS: 315435859
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-22
• Public Version: 1
• Public Version Date: 2022-09-30
• Public Version Status: New
• Public Device Record Key: 7cc7425a-aba0-42b0-93a9-2e32aaba6d1a

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
BWN	TABLE AND ATTACHMENTS, OPERATING-ROOM	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36606	Fluoroscopy/angiography table top	A component of a modular operating table designed as a detachable table top constructed for use during surgical procedures requiring fluoroscopic guidance, such as cardiovascular surgery and other interventional radiology procedures (e.g., biopsy). This table top is typically a one-piece, and completely flat construction with an x-ray translucent section(s) providing x-rays free of artefacts. It is not dedicated to breast biopsy, and not designed to position a patient during other specialist surgeries (i.e., it is not a specialist operating table top with x-ray transparent features).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046768002890	GS1