Supremo Instrumentos

Basic Information

• Brand Name: Supremo Instrumentos
• Primary DI: 07908854001248
• Version / Model: Kit Tunneling VF
• Company Name: ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
• Labeler DUNS: 921478697
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-18
• Public Version: 1
• Public Version Date: 2025-02-26
• Public Version Status: New
• Public Device Record Key: 24330ea7-1586-42bd-a82f-af29eca858df

Device Description

Tunneling VF1/VF2/VF3/VF4 and Case

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZN	Instruments, Dental Hand	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38168	Periosteal elevator, reusable	A hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07908854001248	GS1