Affirm Prone Biopsy System

GUDID 15420045504738

Hologic, Inc.

Mammographic stereotactic biopsy system
Primary Device ID15420045504738
NIH Device Record Keyd692d582-1ccd-4172-ae16-d9e69b6404ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffirm Prone Biopsy System
Version Model Number3D System Software
Company DUNS139534114
Company NameHologic, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045504738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZHSystem, x-ray, mammographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-18

On-Brand Devices [Affirm Prone Biopsy System]

15420045506541ASY-09175
15420045506534ASY-08832
15420045506527ASY-06886
15420045506510PBX-SYS-AFFIRM-3D
15420045506503PBX-SYS-AFFIRM-2D
15420045506497ASY-08178
15420045506480ASY-08176
15420045506473ASY-08175
15420045506466ASY-08174
154200455047383D System Software
15420045504721System Software
15420045510869PBX-SYS-AFFIRM-2D
15420045510852PBX-SYS-AFFIRM-2D
15420045510845PBX-SYS-AFFIRM-2D

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