Intro

Basic Information

• Brand Name: Intro
• Primary DI: 08052440106271
• Version / Model: PT13075
• Catalog Number: PT13075
• Company Name: M.D.L. S.R.L.
• Labeler DUNS: 447228586
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-14
• Public Version: 9
• Public Version Date: 2021-05-27
• Public Version Status: Update
• Public Device Record Key: 0776fb8f-a25c-4e5b-a013-260a9f08c7c5
• Distribution End Date: 2021-05-14

Device Description

COAXIAL INTRODUCER NEEDLE 13G X 75mm

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62257	Orthopaedic coaxial injection applicator	A tubular device with a concentric dual-lumen and a plunger intended to be used during surgery for the percutaneous injection of therapeutic materials (e.g., biologics, bone void fillers, irrigation fluids) into a bone, having been passed over a guidewire to the injection site. Typically, the inner lumen is used for the guidewire and the outer lumen for injection of fluids aided by the plunger. The device is made of metal and/or polymer materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08058341216354	GS1		10	Not in Commercial Distribution	2021-05-14
Primary	08052440106271	GS1

Device Sizes

Type	Value	Unit	Text
Length	75	Millimeter
Needle Gauge	13	Gauge