Intro

Basic Information

• Brand Name: Intro
• Primary DI: 08056138586543
• Version / Model: PT1705
• Catalog Number: PT1705
• Company Name: M.D.L. S.R.L.
• Labeler DUNS: 447228586
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-14
• Public Version: 2
• Public Version Date: 2021-05-27
• Public Version Status: Update
• Public Device Record Key: c2323bb1-3969-42de-a932-aa5fbd9db6ce

Device Description

COAXIAL INTRODUCER NEEDLE 17G X 50mm

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: Yes
• Has Manufacturing Date: No
• 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
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	18056138586540	GS1		10	In Commercial Distribution
Primary	08056138586543	GS1

Device Sizes

Type	Value	Unit	Text
Needle Gauge	17	Gauge
Length	50	Millimeter