FDA.reportPublic FDA data

AFFIRM™ SPECIMEN IMAGING

Primary DI
15420045512931
Brand
AFFIRM™ SPECIMEN IMAGING
Company
Hologic, Inc.
Model
AFFIRM™ SPECIMEN IMAGING
Published
2021-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IZHSystem, x-ray, mammographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZHSystem, X-Ray, MammographicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045512931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551293115420045512931

GMDN Terms#

Term, Definition table
TermDefinition
Mammographic stereotactic biopsy systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
139534114
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06
15420045500518ProcleixUltrio Plus Negative Calibrators3032602014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045518247Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518261Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518278Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518285Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518292Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518087Affirm®Hologic, Inc.IZH2025-07-17
08056977360113SMART FINDER IMS GIOTTO SPAIZH2023-06-25
15420045512948AFFIRM™ CONTRAST BIOPSYHologic, Inc.IZH2020-11-18
00813079020400Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
00813079020417Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
00813079020424Open Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
10813079020407Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
20813079020411Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
10813079020421Open Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
B852SPECBOARD2220SPECBOARD JRMACBRUD CORPORATIONIZH2020-03-18
B852SPECBOARD4440SpecboardMACBRUD CORPORATIONIZH2020-03-18
15420045510845Affirm Prone Biopsy SystemHologic, Inc.IZH2019-09-19
15420045510852Affirm Prone Biopsy SystemHologic, Inc.IZH2019-09-19
15420045510869Affirm Prone Biopsy SystemHologic, Inc.IZH2019-09-19
25420045507347MammoPad Radiolucent CushionHologic, Inc.IZH2018-02-14
15420045507173Affirm Breast Biopsy Guidance SystemHologic, Inc.IZH2017-12-01
15420045507180Affirm Breast Biopsy Guidance SystemHologic, Inc.IZH2017-11-21
15420045507197Affirm Breast Biopsy Guidance SystemHologic, Inc.IZH2017-11-21
25420045507330MammoPad Radiolucent CushionHologic, Inc.IZH2017-07-26
15420045506503Affirm Prone Biopsy SystemHologic, Inc.IZH2017-04-26
15420045506510Affirm Prone Biopsy SystemHologic, Inc.IZH2017-04-26
15420045506534Affirm Prone Biopsy SystemHologic, Inc.IZH2017-04-26
15420045505926Multicare PlatinumHologic, Inc.IZH2017-03-30
15420045506077Digital Spot Mammography System, DSMHologic, Inc.IZH2017-03-30
15420045505858Affirm Breast Biopsy Guidance SystemHologic, Inc.IZH2017-03-18