Selenia FFDM

GUDID 15420045507876

Hologic, Inc.

Stationary mammographic x-ray system, digital

• Primary Device ID: 15420045507876
• NIH Device Record Key: 95930583-9f5f-4a9c-818a-5cca2da06652
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Selenia FFDM
• Version Model Number: 3-000-1528
• Company DUNS: 139534114
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045507876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010025

FDA Product Code

• MUE: Full field digital,system,x-ray,mammographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-16

On-Brand Devices [Selenia FFDM]

• 15420045507920: 4-000-0308
• 15420045507913: ASY-05468
• 15420045507890: 4-000-0144
• 15420045507883: 3-000-4617
• 15420045507876: 3-000-1528
• 15420045507715: FAB-00752
• 15420045507708: FAB-00609
• 15420045507692: 4-000-0293
• 15420045507685: 3-535-0087
• 15420045507678: 3-535-0012
• 15420045507586: FAB-00754
• 15420045507579: FAB-00610
• 15420045507562: FAB-00608
• 15420045507555: 5-000-0073
• 15420045507548: 5-000-0072
• 15420045506060: ASY-07973
• 15420045506053: ASY-06758
• 15420045506046: ASY-06755
• 15420045506039: ASY-06754
• 15420045506022: ASY-06753
• 15420045506015: ASY-06717
• 15420045506008: ASY-06716
• 15420045505995: ASY-06715
• 15420045505988: ASY-06714
• 15420045505971: ASY-01656
• 15420045505964: ASY-01427
• 15420045505957: ASY-01366
• 15420045505940: ASY-00676
• 15420045505933: ASY-00834