SurgiMac

Basic Information

• Brand Name: SurgiMac
• Primary DI: D105SKU131257H02
• Version / Model: 13-1257-H
• Catalog Number: 13-1257-H
• 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: 3e6fbf92-b66e-4dc9-aefd-165a2a0be114

Device Description

Calcium-Hydroxide Placer, Hexa 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
EKI	Carrier, Amalgam, Operative	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35696	Dental amalgam carrier	A hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D105SKU131257H13	HIBCC	Case	100	In Commercial Distribution
Primary	D105SKU131257H02	HIBCC