UNiD™ Calibration Sphere

Basic Information

• Brand Name: UNiD™ Calibration Sphere
• Primary DI: 03613720287971
• Version / Model: A00300032
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Labeler DUNS: 830350380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-20
• Public Version: 3
• Public Version Date: 2023-11-21
• Public Version Status: Update
• Public Device Record Key: 580bf83a-ffdf-48dc-8ddf-8257ad84108e

Device Description

SPHERE A00300032 UNID CALIBRATION SPHERE

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
JAC	System, x-ray, film marking, radiographic	Radiology	892.1640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66940	Radiological image marker, noninvasive, reusable	A non-powered, noninvasive device intended to be placed within the field of view of a radiological device [diagnostic (e.g., x-ray) and/or radiation therapy] to produce an identifying mark [typically for an anatomical location (e.g., mole, nipple, lesion), orientation (e.g., right or left limb), or patient identification] on films or digital images; it is not intended to be used during surgery. It is typically in the form of a small sticker, clip, or plate, and is positioned on or next to the patient, or on the film cassette or holder; it is not intended to be placed on teeth. It is made from materials compatible with the imaging system. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03613720287971	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]