Novo Surgical

Basic Information

• Brand Name: Novo Surgical
• Primary DI: G586G6912460
• Version / Model: G6912-46
• Catalog Number: G6912-46
• 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: d8377967-f2c3-40b5-9b48-8d8593b7e728

Device Description

universal ring retractor magrina vaginal retractor set, includes: 1 #5801-10 (segmented vaginal ring), 1 #5800-01 (vertical table clamp/post), 2 #5800-80 (vaginal blade, lateral), 1 # 5800-03 (post coupling), 1 #5800-81 (vaginal blade, posterior), 1 #5800-05 (horizontal flex bar), 1 #5801-02 (vertical table clamp/post), 4 #5800-65 (tilting blade clamp), 1 #5801-01 (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
45181	Surgical retraction system, reusable	A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G586G6912460	HIBCC

Customer Contacts

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