Novo Surgical Inc.

Basic Information

• Brand Name: Novo Surgical Inc.
• Primary DI: 00842331162503
• Version / Model: E7214-75
• Catalog Number: E7214-75
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-13
• Public Version: 1
• Public Version Date: 2022-11-21
• Public Version Status: New
• Public Device Record Key: 6c5bbaeb-5cd1-46c6-995f-21bd3496bf0d

Device Description

house wire strut guide, 0.6 mm tip w/ notched end, straight shaft, 6 1/2" (16.5 cm)

Device Characteristics

• Single Use: Yes
• 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
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38690	Assistive tie/bow tie	A garment specially designed/adapted to be worn around the neck of a person with a disability as normal decorative attire. It is typically constructed with special fasteners to facilitate easy donning and removal (includes neckties and bow ties).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842331162503	GS1

Customer Contacts

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