SurgiMac

Basic Information

• Brand Name: SurgiMac
• Primary DI: D105SKU1626020
• Version / Model: 16-2602
• Catalog Number: 16-2602s
• Company Name: Surgimac LLC
• Labeler DUNS: 060635048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-22
• Public Version: 1
• Public Version Date: 2024-04-30
• Public Version Status: New
• Public Device Record Key: 8242485c-4156-4ebb-9060-8e0b26260da5

Device Description

Goldman Fox TC, curved, Scissors, Pro Series.

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: 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIR	Scissors, Collar And Crown	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31822	Dental surgical scissors	A hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D105SKU1626021	HIBCC	100	100	In Commercial Distribution
Primary	D105SKU1626020	HIBCC