EVIVA_0913-20 EVIVA_0913-20

GUDID 15420045504974

Hologic, Inc.

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 15420045504974
• NIH Device Record Key: 8af4251c-cbb8-45dc-9088-126e2a9a3114
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIVA_0913-20
• Version Model Number: EVIVA_0913-20
• Catalog Number: EVIVA_0913-20
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	15420045504974 [Primary]
GS1	25420045504971 [Package]; Package: BOX [5 Units]; In Commercial Distribution
GS1	35420045504978 [Package]; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180233

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

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

[15420045504974]

Radiation Sterilization

[15420045504974]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-07-12
• Device Publish Date: 2016-07-26

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• 15420045516991 - Aptima®: 2025-03-24 Aptima® SARS-CoV-2 Assay, 100 test, box 1 of 2 (2°C to 8°C box).
• 15420045517004 - Aptima®: 2025-03-24 Aptima® SARS-CoV-2 Assay, 100 test, box 2 of 2 (15°C to 30°C box).
• 15420045517035 - Aptima®: 2025-03-24 Aptima® SARS-CoV-2 Assay Controls Kit.
• 15420045517059 - Aptima®: 2024-12-27 Aptima® BV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test
• 15420045517066 - Aptima®: 2024-12-27 Aptima® BV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® BV assay is an in vitro nucleic acid amplification te