Mammotome Revolve EX CA000460001

GUDID 10841911102349

Revolve EX Ultrasound Probe with Sleeve - System Registered- CE

DEVICOR MEDICAL PRODUCTS, INC.

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 10841911102349
• NIH Device Record Key: b9b5076d-39b2-4192-a4a6-b90ac8dde12d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome Revolve EX
• Version Model Number: MHEX08S
• Catalog Number: CA000460001
• Company DUNS: 961832156
• Company Name: DEVICOR MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911102342 [Primary]
GS1	10841911102349 [Package]; Contains: 00841911102342; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202012

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: 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