Selenia Dimensions ASY-11739

GUDID 25420045512334

Hologic, Inc.

Stationary mammographic x-ray system, digital

• Primary Device ID: 25420045512334
• NIH Device Record Key: 79f970f7-8c49-4df0-acdf-72b5ad020c0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Selenia Dimensions
• Version Model Number: ASY-11739
• Catalog Number: ASY-11739
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	25420045512334 [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: 1
• Public Version Date: 2019-11-26
• Device Publish Date: 2019-11-18

On-Brand Devices [Selenia Dimensions]

• 15420045507500: ASY-10775
• 15420045507203: ASY-05469
• 15420045507166: ASY-02275
• 15420045507159: ASY-02165
• 15420045507142: ASY-02164
• 15420045507135: ASY-02163
• 15420045507128: ASY-02162
• 15420045507111: ASY-02037
• 15420045507104: ASY-02036
• 15420045507098: ASY-02028
• 15420045507081: ASY-01994
• 15420045507074: ASY-01993
• 15420045507067: ASY-01986
• 15420045507050: ASY-01985
• 15420045507043: ASY-01950
• 15420045507036: ASY-01946
• 15420045507029: ASY-01945
• 15420045507012: ASY-01940
• 15420045506930: ASY-08499
• 15420045506923: ASY-08500
• 15420045505674: ASY-03342
• 15420045505650: PRD-01702
• 15420045505643: PRD-01702
• 15420045505636: ASY-04160
• 15420045505629: ASY-08483
• 15420045505612: ASY-08482
• 15420045505605: ASY-07460
• 15420045505599: ASY-03339
• 15420045505582: ASY-01966
• 15420045505575: ASY-06202
• 15420045505568: ASY-03694
• 25420045512341: ASY-11738
• 25420045512334: ASY-11739
• 15420045512344: ASY-11738
• 15420045512337: ASY-11739
• 25420045512358: ASY-13532
• 15420045512351: ASY-13532
• 15420045514713: ASY-04160
• 15420045514706: RM-ASY-04160