Integra® Ruggles®-Redmond™

Basic Information

• Brand Name: Integra® Ruggles®-Redmond™
• Primary DI: 10381780229605
• Version / Model: RN0076
• Catalog Number: RN0076
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-02
• Public Version: 4
• Public Version Date: 2023-05-11
• Public Version Status: Update
• Public Device Record Key: 004754ab-54e1-43fe-86f9-703d65665036

Device Description

Integra® Ruggles®-Redmond™ Strully-Gigli Saw Handles, Loop Style, Blade Lock, Pair

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
GDR	SAW, MANUAL AND ACCESSORIES	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44982	Manual surgical saw blade, flexible, reusable	A flexible, wire-like, metal surgical instrument, usually of a high-grade stainless steel, typically intended to be used in orthopaedic or neurological surgery to cut bone. It has a serrated surface, or a surface coated with an abrasive material, and functions as the cutting blade of a flexible manual hand saw commonly known as a Gigli saw. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M274RN00761	HIBCC
Primary	10381780229605	GS1

Customer Contacts

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