Unity

Basic Information

• Brand Name: Unity
• Primary DI: 08800039822244
• Version / Model: A
• Catalog Number: SI.IN.0004
• Company Name: DIOMEDICAL CO.,LTD.
• Labeler DUNS: 557795909
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-19
• Public Version: 1
• Public Version Date: 2019-07-29
• Public Version Status: New
• Public Device Record Key: 7ffe591e-f20a-4d63-974f-c9808a4d9249

Device Description

SIJ 6mm Dialator

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: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUR	Sacroiliac joint fixation	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37151	Laparoscopic access cannula dilator	A hollow dilator with a tapered distal end intended to enable the gentle insertion of a larger laparoscopic access cannula, necessary when significantly increasing the working access port's lumen, e.g., from 10 to 20 mm diameter. It is commonly used in minimally-invasive laparoscopic procedures. The dilator is entered over a guide rod, forcing a larger opening as the skin is pressed aside, thereby reducing the possible degree of damage. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800039822244	GS1

Customer Contacts

• Phone: [phone] ext. 112
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173201	000