MEDONE

Basic Information

• Brand Name: MEDONE
• Primary DI: 08052286423976
• Version / Model: MO18250-K0
• Company Name: MEDAX SRL UNIPERSONALE
• Labeler DUNS: 440211428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-15
• Public Version: 1
• Public Version Date: 2021-01-25
• Public Version Status: New
• Public Device Record Key: fadd8421-41a1-4702-86c1-49dc9f158c9a

Device Description

Soft Tissue Automatic Biopsy System 18G x 250mm

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: Yes
• MRI Safety: MR Unsafe
• 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
KNW	Instrument, Biopsy	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16835	Soft-tissue biopsy procedure kit, non-medicated	A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18052286423973	GS1		10	In Commercial Distribution
Primary	08052286423976	GS1

Premarket Submissions

Submission Number	Supplement Number
K172344	000