ATEC Introducer ILS 0914-12-OB

GUDID 05420045503796

Hologic, Inc.

Imaging lesion localization marker, implantable

• Primary Device ID: 05420045503796
• NIH Device Record Key: e8ed176e-53fa-4998-abd7-54d94acadbf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATEC Introducer
• Version Model Number: ILS 0914-12-OB
• Catalog Number: ILS 0914-12-OB
• 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	05420045503796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042290

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

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

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

Radiation Sterilization

[05420045503796]

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: 2016-08-11

On-Brand Devices [ATEC Introducer]

• 05420045503796: ILS 0914-12-OB
• 05420045503789: ILS 0914-20-OB
• 05420045503208: ILS 0914-20
• 05420045503192: ILS 0914-12
• 15420045504592: AI121220
• 15420045504585: AI120920
• 15420045504578: AI091220
• 15420045504561: AI090920