SmartMix™ Curettes

Basic Information

• Brand Name: SmartMix™ Curettes
• Primary DI: 15060238201305
• Version / Model: 5401-10-002
• Company Name: SUMMIT MEDICAL LIMITED
• Labeler DUNS: 221751311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-24
• Public Version: 1
• Public Version Date: 2022-12-02
• Public Version Status: New
• Public Device Record Key: 12837350-fa84-45f2-b45d-f8553512c02e

Device Description

Curettes

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HTF	Curette	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47735	Orthopaedic cement curette	A sterile, hand-held, manual surgical instrument designed to remove excess orthopaedic bone cement from an implantation site during the cementing of a prosthesis. It is typically made of plastic materials and consists of a handle proximally and a concave, spoon-like tip that is angled at the distal end, or it may be double-ended with the handle placed centrally. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	25060238201302	GS1	Carton	10	In Commercial Distribution
Primary	15060238201305	GS1