Mammotome Revolve EX CA000503001

GUDID 00841911102335

Revolve EX Ultrasound Holster - CE

DEVICOR MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system

• Primary Device ID: 00841911102335
• NIH Device Record Key: d5790a94-ae6b-48b4-820c-40b000532edd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome Revolve EX
• Version Model Number: MHEXH1
• Catalog Number: CA000503001
• Company DUNS: 961832156
• Company Name: DEVICOR MEDICAL PRODUCTS, INC.
• 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	00841911102335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202012

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: 2025-09-05
• Device Publish Date: 2025-08-28

On-Brand Devices [Mammotome Revolve EX]

• 10841911102509: Revolve EX Ultrasound Probe with Sleeve - CD
• 00841911102366: Revolve EX Ultrasound Holster Holder - CE
• 10841911102349: Revolve EX Ultrasound Probe with Sleeve - System Registered- CE
• 00841911102335: Revolve EX Ultrasound Holster - CE