MammoPad Radiolucent Cushion MP301-T

GUDID 25420045506951

Hologic, Inc.

Radiological breast positioner, non-wearable

• Primary Device ID: 25420045506951
• NIH Device Record Key: 96ade932-60b4-4821-9d1b-d02dbc2a8731
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MammoPad Radiolucent Cushion
• Version Model Number: MP301-T
• Catalog Number: MP301-T
• Company DUNS: 139534114
• Company Name: Hologic, Inc.
• Device Count: 10
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045506954 [Unit of Use]
GS1	25420045506951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062141

FDA Product Code

• IZH: System, x-ray, mammographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-11-15

On-Brand Devices [MammoPad Radiolucent Cushion]

• 45420045505811: MP301-T
• 45420045505804: MP301-D
• 45420045505798: MP301
• 45420045505781: MP201
• 45420045505668: MP101
• 25420045507347: MP201-10
• 25420045507330: MP301-10
• 25420045506951: MP301-T
• 25420045506944: MP301-D