Centesis Procedure Tray

Basic Information

• Brand Name: Centesis Procedure Tray
• Primary DI: 00886333220434
• Version / Model: A30-CE3CO
• Catalog Number: A30-CE3CO
• 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: 2022-07-20
• Public Version: 2
• Public Version Date: 2024-01-16
• Public Version Status: Update
• Public Device Record Key: eb360855-1d8b-4200-a48c-d6ec533c24a6
• Distribution End Date: 2024-01-15

Device Description

Centesis Procedure Tray without Catheter

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
OJT	Aspiration Tray	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36142	Aspiration tray, single-use	A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886333220438	GS1	Box	10	Not in Commercial Distribution	2024-01-15
Primary	00886333220434	GS1

Customer Contacts

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