Nivo

Basic Information

• Brand Name: Nivo
• Primary DI: 08964003163440
• Version / Model: NISC45
• Company Name: B. Ali Impex
• Labeler DUNS: 645802117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-27
• Public Version: 1
• Public Version Date: 2024-02-05
• Public Version Status: New
• Public Device Record Key: c2cef369-dcc8-491a-8ca1-5703d77f58fa

Device Description

Iris Scissors Standard Curved 4.5”

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGN	Scissors, Surgical Tissue, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63480	Blepharoplasty scissors	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut eyelid tissue during plastic surgery of the eyelids (blepharoplasty). It comprises two pivoted blades that usually have finger and thumb ring-handles, and which cut with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes. It is not intended for intraocular surgery. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08964003163440	GS1