ATEC Introducer AI120920

GUDID 15420045504585

Hologic, Inc.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 15420045504585
• NIH Device Record Key: 18f12a4e-6380-4f88-a877-2a8b4f886b21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATEC Introducer
• Version Model Number: AI120920
• Catalog Number: AI120920
• 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
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045504585 [Primary]
GS1	25420045504582 [Package]; Package: BOX [5 Units]; In Commercial Distribution

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

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

Radiation Sterilization

[15420045504585]

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