Pro-Mag Ultra 2.2 Automatic Biopsy Instrument

Basic Information

• Brand Name: Pro-Mag Ultra 2.2 Automatic Biopsy Instrument
• Primary DI: 20886333007213
• Version / Model: 7677
• Catalog Number: 7677
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 3
• Public Version Date: 2018-12-21
• Public Version Status: Update
• Public Device Record Key: f83d5fdd-f2d6-4867-891f-d8c39bef58b8

Device Description

Pro-Mag Ultra 2.2 Automatic Biopsy Instrument

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
35286	Biopsy punch, reusable	A manual surgical instrument designed to obtain a tissue or bone sample typically for histopathological analysis. The instrument may be ring-handled, pistol grip, or shaft-like in design. Ring-handled or pistol grip designs feature extended shafts which terminate in a punch-like or mechanical jaw mechanism at the distal tip. The shaft-like instrument is a hollow tube, sharpened on one end, and is usually used with a trocar. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20886333007213	GS1

Customer Contacts

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