DUNLEE 989603216911

GUDID 00884838123045

The 16 Breast Coil is a Phased Array Receive Only MRI Coil. It is a variable 16 CH Breast coil for both diagnostic imaging and biopsy procedures. The coil consists of a Patient Support, a Headrest, two 4CH Lateral coils (left and right), an 8CH Medial Array Coil and various other pads and supports.

Philips Medical Systems Nederland B.V.

MRI system coil, radio-frequency

• Primary Device ID: 00884838123045
• NIH Device Record Key: b8df6761-b2ad-4a78-8896-c50055f5ba49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUNLEE
• Version Model Number: 16 BREAST COIL
• Catalog Number: 989603216911
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838123045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233348

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-31
• Device Publish Date: 2025-12-23

On-Brand Devices [DUNLEE]

• 00884838117761: 1.5 T/R Quad Extremity Coil
• 00884838117785: 1.5T 8CH T/R Knee Coil
• 00884838123045: The 16 Breast Coil is a Phased Array Receive Only MRI Coil. It is a variable 16 CH Breast coil f