ATEC

GUDID 15420045509801

Hologic, Inc.

Mammographic stereotactic biopsy system

• Primary Device ID: 15420045509801
• NIH Device Record Key: 50b76191-3263-4ac0-8238-4d4173f59025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATEC
• Version Model Number: SR3000-01
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	15420045509801 [Primary]

FDA Product Code

• PXP: Breast biopsy / localization tray

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: 2019-04-10
• Device Publish Date: 2019-04-02

On-Brand Devices [ATEC]

• 05420045503178: ATEC RTFA
• 05420045503161: ATEC TF-1
• 15420045503182: ATEC Canister
• 15420045509849: ATEC STXFISCHER
• 15420045509832: ATEC STX-2
• 15420045509825: ATEC STX-1
• 15420045509818: SR3000-04
• 15420045509801: SR3000-01
• 15420045509795: SR3090-01
• 15420045509788: SR3060-01
• 15420045506428: MME-01782
• 15420045506411: MME-00345