NC32 INTRABEAM® Floor Stand

Basic Information

• Brand Name: NC32 INTRABEAM® Floor Stand
• Primary DI: 04049539101761
• Version / Model: 000000-1096-945
• Company Name: Carl Zeiss Meditec AG
• Labeler DUNS: 342228620
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c31136b8-b49e-4db1-b75c-3fe2adb656c4

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
KMN	Chair And Table, Medical	General Hospital	880.6140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59677	Intraoperative/postoperative therapeutic x-ray system	A mobile (on wheels) assembly of mains electricity (AC-powered) devices designed to produce low-energy x-rays used for therapeutic purposes, primarily in the treatment of cancer (e.g., breast, brain, skin) typically during or after an operation for tumour resection. It uses a miniature electronic X-ray source (50kV maximum) attached to one of various types and sizes of applicators specific to the clinical application (e.g., from within a resected breast tumour site). It typically consists of an x-ray source and an applicator mounted on a floor stand, verification tools, control unit, and user interface. It may be used in an operating room (OR) or other clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049539101761	GS1