Soft Tissue Biopsy Tray

Basic Information

• Brand Name: Soft Tissue Biopsy Tray
• Primary DI: 00886333220465
• Version / Model: A32-ST1SF
• Catalog Number: A32-ST1SF
• 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: 5cb8d1d3-cbd5-4bab-adc0-341811b823f6
• Distribution End Date: 2024-01-15

Device Description

CT Soft Tissue Biopsy Tray with Safety Devices

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
61922	Soft-tissue biopsy procedure kit, medicated	A collection of sterile devices, which includes a pharmaceutical(s), designed to perform a non-specific soft tissue biopsy (e.g., skin biopsy, breast biopsy); it is not dedicated to biopsy of a specific internal organ. It includes the biopsy needle used for this procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886333220469	GS1	Box	10	Not in Commercial Distribution	2024-01-15
Primary	00886333220465	GS1

Customer Contacts

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