MEDINAUT Plus Kyphoplasty System

Basic Information

• Brand Name: MEDINAUT Plus Kyphoplasty System
• Primary DI: 08809544175241
• Version / Model: PICD-CA2/ PICD-NDT2
• Company Name: IMEDICOM CO., LTD.
• Labeler DUNS: 690340653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-31
• Public Version: 1
• Public Version Date: 2019-06-10
• Public Version Status: New
• Public Device Record Key: 303ceeab-846b-4736-83f0-8d451c3c0a72

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: No
• 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
HRX	Arthroscope	Orthopedic	888.1100	2
HXG	Tamp	Orthopedic	888.4540	1
NDN	Cement, Bone, Vertebroplasty	Orthopedic	888.3027	2

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
Primary	08809544175241	GS1

Premarket Submissions

Submission Number	Supplement Number
K182287	000