STRADIS HEALTHCARE

Basic Information

• Brand Name: STRADIS HEALTHCARE
• Primary DI: M75257026900
• Version / Model: 570-2690
• Company Name: STRADIS MEDICAL, LLC
• Labeler DUNS: 174262477
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-17
• Public Version: 1
• Public Version Date: 2023-01-25
• Public Version Status: New
• Public Device Record Key: cc64ff1d-6e2a-4e81-aea4-862976ab8993
• Distribution End Date: 2023-01-24

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OFX	General Purpose Dental Tray	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64010	Orthodontic appliance/positioning tray kit	A collection of dental devices which includes a custom-made positioning tray (indirect bonding tray) intended to position and hold in place a set of included orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) to bond them to teeth during a single procedure. The components are typically made of synthetic polymer and/or metal materials and include appliances manufactured from an oral cavity impression or oral scan for a specific patient (custom-made). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M75257026900	HIBCC

Customer Contacts

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