DRGEM

Basic Information

• Brand Name: DRGEM
• Primary DI: 08800011103026
• Version / Model: TS-FC6
• Company Name: DRGEM Corporation
• Labeler DUNS: 688477319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-29
• Public Version: 4
• Public Version Date: 2021-08-09
• Public Version Status: Update
• Public Device Record Key: 518c5ea2-5167-4598-b22c-ed4bc818637d

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
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	892.1770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37076	X-ray system tube support, floor standing	A component of an x-ray system (diagnostic, therapeutic, radiation therapy simulator) intended to be placed on the floor to mount, support and facilitate positioning of the x-ray tube assembly (not included). It typically consists of a rack with controls mounted on a base plate. The x-ray tube assembly is attached to the rack and can be moved along the rack and/or tilted. Some designs also support the movement and positioning of an image receptor assembly (e.g., C-arm assembly).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800011103026	GS1