Mammosite 919004

GUDID 15420045509955

Patient Care Kit

Hologic, Inc.

Breast brachytherapy system applicator, remote-afterloading

• Primary Device ID: 15420045509955
• NIH Device Record Key: fbe3b003-f181-45ce-97ad-eee2e5a2660c
• Commercial Distribution Discontinuation: 2023-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Mammosite
• Version Model Number: 919004
• Catalog Number: 919004
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Celsius and 86 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Celsius and 86 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Celsius and 86 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Celsius and 86 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Celsius and 86 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Celsius and 86 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Celsius and 86 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Celsius and 86 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Celsius and 86 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Celsius and 86 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Celsius and 86 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045509955 [Primary]

FDA Product Code

• PYB: Minor surgical procedures tray

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-05-03
• Device Publish Date: 2019-07-30

On-Brand Devices [Mammosite]

• 15420045509979: CONTURA®/MAMMOSITE ACCESSORY KIT
• 15420045509955: Patient Care Kit