HiVac™ Syringe Bone Cement Mixing and Delivery System

Basic Information

• Brand Name: HiVac™ Syringe Bone Cement Mixing and Delivery System
• Primary DI: 15060238200674
• Version / Model: S727
• Company Name: SUMMIT MEDICAL LIMITED
• Labeler DUNS: 221751311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-01
• Public Version: 2
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 0c214bde-3336-4da4-8d26-788a65960696

Device Description

Bone Cement Mixing and Delivery System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
KIH	Dispenser, Cement	Orthopedic	888.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45253	Orthopaedic cement preparation/delivery kit	A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	25060238200671	GS1	Carton	10	In Commercial Distribution
Primary	15060238200674	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]