Spinal Biopsy Needle with Echogenic Tip

Basic Information

• Brand Name: Spinal Biopsy Needle with Echogenic Tip
• Primary DI: 00886333002986
• Version / Model: MSPN2206US
• Catalog Number: MSPN2206US
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0dfe2c28-7a94-4a84-863b-cee718400455

Device Description

Spinal Biopsy Needle with Echogenic Tip 22ga x 15cm

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
KNW	Instrument, Biopsy	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47540	Soft-tissue biopsy needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886333002980	GS1	Box	10	In Commercial Distribution
Primary	00886333002986	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K980122	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			22ga x 15cm