NA

Basic Information

• Brand Name: NA
• Primary DI: 00840682102674
• Version / Model: 5380966
• Company Name: Hangwei GE Medical Systems Co., Ltd.
• Labeler DUNS: 654659689
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-28
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f09604ef-dce2-47e7-aa86-b5412df4c5cd

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
IZZ	Table, radiographic, non-tilting, powered	Radiology	892.1980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40656	CT system table	A powered/programmable table that has electronic and/or software controls for table top height and positioning and is specifically designed to position and support a patient during diagnostic examinations involving the use of an x-ray computed tomography (CT) system; it is not primarily intended for interventional procedures/surgery. It is typically an integral component of a CT system design or gantry configuration and can be flat or curved and made of radiolucent materials with low x-ray attenuation coefficients.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682102674	GS1