Integra® Ruggles®-Redmond™

Basic Information

• Brand Name: Integra® Ruggles®-Redmond™
• Primary DI: 10381780225614
• Version / Model: R8876
• Catalog Number: R8876
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-01
• Public Version: 3
• Public Version Date: 2023-05-05
• Public Version Status: Update
• Public Device Record Key: d82b630a-5686-4c28-9b3e-c9903e256351

Device Description

Integra® Ruggles®-Redmond™ Fukushima-Chen Tumor Knife, 7-1/2", Bayonet, Sharp, Blunt Tip

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
GZX	INSTRUMENT, MICROSURGICAL	Neurology	882.4525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61100	Neurosurgical probe	A non-sterile, slender, rod-like, hand-held manual surgical instrument, typically made of metal, with an angled tip and a handle, designed for exploring/dissecting intracranial structures during a surgical procedure (e.g., tumour removal, third ventriculostomy, cyst fenestration). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M274R88761	HIBCC
Primary	10381780225614	GS1

Customer Contacts

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