Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780204275
• Version / Model: 70-5105
• Catalog Number: 70-5105
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-18
• Public Version: 5
• Public Version Date: 2022-07-19
• Public Version Status: Update
• Public Device Record Key: 77ff04c7-629a-4298-8d4f-b98dfa63f3c2
• Distribution End Date: 2022-05-01

Device Description

Curette, Gracey 9-10, Double-Ended, GripLite®

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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMS	CURETTE, PERIODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41660	Periodontal curette	A hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H8347051050	HIBCC
Primary	10381780204275	GS1

Customer Contacts

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