Mammotome Prima CA000852001

GUDID 00841911102281

Mammotome Prima MR Control Module - CE

DEVICOR MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system

• Primary Device ID: 00841911102281
• NIH Device Record Key: 350872e6-fcf7-4594-a8ee-7be25dc492eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome Prima
• Version Model Number: MRCM1
• Catalog Number: CA000852001
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00841911102281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K260365

FDA Product Code

• KNW: Instrument, Biopsy

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: 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