Novo Surgical

Basic Information

• Brand Name: Novo Surgical
• Primary DI: G586G6912560
• Version / Model: G6912-56
• Catalog Number: G6912-56
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-18
• Public Version: 1
• Public Version Date: 2023-12-26
• Public Version Status: New
• Public Device Record Key: 6f6ba99f-92fb-4018-b1dd-c0dfae94ea58

Device Description

universal ring retractor pediatric set, includes: 1 #5800-01 (vertical table clamp/post), 2 #5800-09 (kelly blade), 1 #5800-27 (kelly blade), 1 #5800-29 (kelly blade), 1 #5800-03 (post coupling), 1 #5800-05 (horizontal flex bar), 6 #5800-65 (tilting blade clamp), 1 # 5800-40 (malleable blade), 2 #5800-41 (malleable blade), 2 #5800-42 (malleable blade), 1 #5800-44 (malleable blade), 1 #5800-62 (round ring), 1 #5800-58s (oval segmented ring), 1 #5845-01 (richardson blade), 1 #5845-02 (richardson blade), 1 #5845-03 (richardson blade), 1 #5800-36 (harrington blade), 1 #5801-03 (magrina vaginal retractor deaver blade)

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
GAD	RETRACTOR	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46774	Surgical retractor/retraction system blade, reusable	A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths 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	G586G6912560	HIBCC

Customer Contacts

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