Sertera Biopsy Device Sertera-14

GUDID 25420045504063

Hologic, Inc.

Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle

• Primary Device ID: 25420045504063
• NIH Device Record Key: e8975db1-3560-41e5-a7e3-f72cc8bb0787
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sertera Biopsy Device
• Version Model Number: Sertera-14
• Catalog Number: Sertera-14
• Company DUNS: 018925968
• 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: 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
• 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	25420045504063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150169

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

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

[25420045504063]

Radiation Sterilization

[25420045504063]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-14

On-Brand Devices [Sertera Biopsy Device]

• 25420045504063: Sertera-14
• 25420045504056: Sertera-12
• 15420045504066: Sertera-14
• 15420045504059: Sertera-12