Raw Surgical Corporation

Basic Information

• Brand Name: Raw Surgical Corporation
• Primary DI: G508RSCFB654R0
• Version / Model: Guide, Eyed
• Catalog Number: RSC-FB654R
• Company Name: RAW SURGICAL CORPORATION
• Labeler DUNS: 850405913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-01
• Public Version: 1
• Public Version Date: 2023-12-11
• Public Version Status: New
• Public Device Record Key: 5ffc418e-a998-43b4-b93c-6d81340f0979

Device Description

Guide, Eyed, 6.4mm, 9 1/2", for RSC-FB651R Rumel Tournequet

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
HAO	Instrument, Surgical, Non-Powered	Neurology	882.4535	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35335	Dura mater dissector	A hand-held surgical instrument, usually softly rounded and curved at the working end, used to separate the outermost membrane covering of the brain and spinal cord from the inner membranes. It is usually designed with a handle which continues into a shaft that terminates at the distal end with a rounded curved tip, or it can be double-ended. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G508RSCFB654R0	HIBCC