Techna-Cut™ Biopsy Needle

Basic Information

• Brand Name: Techna-Cut™ Biopsy Needle
• Primary DI: 00886333003396
• Version / Model: TCBN2107X
• Catalog Number: TCBN2107X
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2024-02-02
• Public Version Status: Update
• Public Device Record Key: dc11acb6-bf22-4f8d-a59b-371338c1d84d
• Distribution End Date: 2024-02-01

Device Description

Techna-Cut™ Biopsy Needle 21ga x 7cm

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
35886	Body aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886333003390	GS1	Box	10	Not in Commercial Distribution	2024-02-01
Primary	00886333003396	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			21ga x 7cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry and Away from Sunlight