Mammotome Prima CA000784001

GUDID 00841911100508

Mammotome Prima MR Disposable Targeting Set for 8 gauge, 14.5cm probe - CE

DEVICOR MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system

• Primary Device ID: 00841911100508
• NIH Device Record Key: 632a836f-e3e8-47ff-ab75-d7e18f3ea845
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome Prima
• Version Model Number: MRTARGET08
• Catalog Number: CA000784001
• Company DUNS: 961832156
• Company Name: DEVICOR MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00841911100508 [Primary]
GS1	10841911100505 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K260365

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-23
• Device Publish Date: 2026-03-13

On-Brand Devices [Mammotome Prima]

• 00841911102632: Mammotome Prima MR Battery - CE
• 00841911102496: Mammotome Prima MR Battery Charger - CE
• 00841911102489: Mammotome Prima Reusable Tray - CE
• 00841911102458: Mammotome Prima MR Foot Switch - CE
• 00841911102281: Mammotome Prima MR Control Module - CE
• 00841911100508: Mammotome Prima MR Disposable Targeting Set for 8 gauge, 14.5cm probe - CE