Home GUDID 15420045510852 Affirm Prone Biopsy System
Primary DI 15420045510852
Brand Affirm Prone Biopsy System
Company Hologic, Inc.
Model PBX-SYS-AFFIRM-2D
Catalog number PBX-SYS-AFFIRM-2D
Published 2019-09-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name IZH System, x-ray, mammographic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IZH System, X-Ray, Mammographic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 15420045510852 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 15420045510852 15420045510852
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 139534114 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 15420045518247 Affirm Prone Biopsy System Hologic, Inc. IZH 2026-03-12 15420045518261 Affirm Prone Biopsy System Hologic, Inc. IZH 2026-03-12 15420045518278 Affirm Prone Biopsy System Hologic, Inc. IZH 2026-03-12 15420045518285 Affirm Prone Biopsy System Hologic, Inc. IZH 2026-03-12 15420045518292 Affirm Prone Biopsy System Hologic, Inc. IZH 2026-03-12 15420045518087 Affirm® Hologic, Inc. IZH 2025-07-17 08056977360113 SMART FINDER IMS GIOTTO SPA IZH 2023-06-25 15420045512931 AFFIRM™ SPECIMEN IMAGING Hologic, Inc. IZH 2021-07-10 15420045512948 AFFIRM™ CONTRAST BIOPSY Hologic, Inc. IZH 2020-11-18 00813079020400 Closed Needle Guide REMINGTON MEDICAL, INC. IZH 2020-09-24 00813079020417 Closed Needle Guide REMINGTON MEDICAL, INC. IZH 2020-09-24 00813079020424 Open Needle Guide REMINGTON MEDICAL, INC. IZH 2020-09-24 10813079020407 Closed Needle Guide REMINGTON MEDICAL, INC. IZH 2020-09-24 20813079020411 Closed Needle Guide REMINGTON MEDICAL, INC. IZH 2020-09-24 10813079020421 Open Needle Guide REMINGTON MEDICAL, INC. IZH 2020-09-24 B852SPECBOARD2220 SPECBOARD JR MACBRUD CORPORATION IZH 2020-03-18 B852SPECBOARD4440 Specboard MACBRUD CORPORATION IZH 2020-03-18 15420045510845 Affirm Prone Biopsy System Hologic, Inc. IZH 2019-09-19 15420045510869 Affirm Prone Biopsy System Hologic, Inc. IZH 2019-09-19 25420045507347 MammoPad Radiolucent Cushion Hologic, Inc. IZH 2018-02-14 15420045507173 Affirm Breast Biopsy Guidance System Hologic, Inc. IZH 2017-12-01 15420045507180 Affirm Breast Biopsy Guidance System Hologic, Inc. IZH 2017-11-21 15420045507197 Affirm Breast Biopsy Guidance System Hologic, Inc. IZH 2017-11-21 25420045507330 MammoPad Radiolucent Cushion Hologic, Inc. IZH 2017-07-26 15420045506503 Affirm Prone Biopsy System Hologic, Inc. IZH 2017-04-26 15420045506510 Affirm Prone Biopsy System Hologic, Inc. IZH 2017-04-26 15420045506534 Affirm Prone Biopsy System Hologic, Inc. IZH 2017-04-26 15420045505926 Multicare Platinum Hologic, Inc. IZH 2017-03-30 15420045506077 Digital Spot Mammography System, DSM Hologic, Inc. IZH 2017-03-30 15420045505858 Affirm Breast Biopsy Guidance System Hologic, Inc. IZH 2017-03-18