Discectomy Set

Basic Information

• Brand Name: Discectomy Set
• Primary DI: M7403030115
• Version / Model: 15-02-05
• Catalog Number: 303-0115
• Company Name: SPINEOLOGY INC.
• Labeler DUNS: 033014361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-12
• Public Version: 1
• Public Version Date: 2024-01-22
• Public Version Status: New
• Public Device Record Key: 92d4db08-6ca0-4b50-a4d3-ed92e1f508a9

Device Description

3x7mm Introducer Paddle

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: MR Unsafe
• 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13371	Viscera retention paddle	A sterile, hand-held, flat device designed to be temporarily placed within a body cavity to retain and protect organs (i.e., viscera) while the surgeon performs a suturing procedure (typically internal wound closure). It is in the form of a thin, flexible, synthetic polymer paddle that may have an attached cord that remains outside the body to assist in device removal prior to external wound closure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7403030115	HIBCC

Customer Contacts

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