ASPIRATION NEEDLE

Basic Information

• Brand Name: ASPIRATION NEEDLE
• Primary DI: 04953170035302
• Version / Model: NA-2C-1
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 4
• Public Version Date: 2022-08-19
• Public Version Status: Update
• Public Device Record Key: 54df5b4b-34b2-48d0-8f8e-430377de7d2a
• Distribution End Date: 2022-08-18

Device Description

This model includes one of sheath section and six of needle sections. The sheath section is reusable and requires autoclave sterilization prior to use. The needle section is single-use and packaged as sterile. Please refer to the instruction manual for details.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDM	NEEDLE, ASPIRATION AND INJECTION, REUSABLE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38825	General-purpose endoscopic needle, single-use	A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14953170035309	GS1		6	Not in Commercial Distribution	2022-08-18
Primary	04953170035302	GS1

Customer Contacts

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