Affirm Prone Biopsy System

Basic Information

• Brand Name: Affirm Prone Biopsy System
• Primary DI: 15420045510869
• Version / Model: PBX-SYS-AFFIRM-2D
• Catalog Number: PBX-SYS-AFFIRM-2D
• Company Name: Hologic, Inc.
• Labeler DUNS: 139534114
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-19
• Public Version: 1
• Public Version Date: 2019-09-27
• Public Version Status: New
• Public Device Record Key: 78faea8c-b1cc-4c88-8924-98c9fd404feb

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
IZH	System, x-ray, mammographic	Radiology	892.1710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36190	Mammographic stereotactic biopsy system	An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045510869	GS1

Premarket Submissions

Submission Number	Supplement Number
K153486	000