HYGITECH

Basic Information

• Brand Name: HYGITECH
• Primary DI: 03615140005661
• Version / Model: HY-98033
• Catalog Number: HY-98033
• Company Name: HYGITECH
• Labeler DUNS: 279456896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-16
• Public Version: 1
• Public Version Date: 2020-12-24
• Public Version Status: New
• Public Device Record Key: 512b8ee1-e78d-49ce-b5b5-98aac4b539a5

Device Description

IM2P surgery tip compatible Mectron HYGITECH Reference: HY-98033 Surgery tip with marking used during the preparation of the implant bed, especially for bone perforation. Particularly effective in the case of pilot osteotomy in the anterior and posterior (maxillary) region, or optional to check the alignment of the axis of the preparations 2 PIN 2-2.4 Diameter: 2 mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJB	Handle, Instrument, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10455	Bone cutter	A strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03615140005661	GS1