Hexa

Basic Information

• Brand Name: Hexa
• Primary DI: 00850057092004
• Version / Model: PSS15C
• Company Name: Hexa Dental
• Labeler DUNS: 096955608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-05
• Public Version: 1
• Public Version Date: 2023-12-13
• Public Version Status: New
• Public Device Record Key: 6c8ce94f-aee3-4e03-b03c-e6b24d6715a1

Device Description

Hexa Surgical Blade #15C Stainless Steel

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GFA	BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65310	Manual surgical saw blade, flexible, single-use	A flexible, wire-like, metal surgical instrument, usually of a high-grade stainless steel, typically intended to be used in orthopaedic or neurological surgery to cut bone. It has a serrated surface, or a surface coated with an abrasive material, and functions as the cutting blade of a flexible manual hand saw commonly known as a Gigli saw. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850057092004	GS1