Control Module- Revolve EX CA000606001

GUDID 00841911102830

Control Module Revolve EX - ROW

DEVICOR MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system

• Primary Device ID: 00841911102830
• NIH Device Record Key: 11894494-776e-4a55-a7be-efe0268f7608
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control Module- Revolve EX
• Version Model Number: MSCM1
• Catalog Number: CA000606001
• 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: true
• 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	00841911102830 [Primary]

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: 2025-05-16
• Device Publish Date: 2025-05-08

Devices Manufactured by DEVICOR MEDICAL PRODUCTS, INC.

• 00841911102830 - Control Module- Revolve EX: 2025-05-16Control Module Revolve EX - ROW
• 00841911102830 - Control Module- Revolve EX: 2025-05-16 Control Module Revolve EX - ROW
• 00841911103165 - Mammotome Revolve: 2024-11-28 Mammotome Revolve Control Module
• 00841911102731 - Mammotome revolve: 2024-10-15 Stereotactic Probe - Non-Glass Falcon - CE
• 10841911102745 - Mammotome revolve: 2024-10-15 Stereotactic Probe - Non-Glass Falcon - CE
• 10841911102752 - Mammotome revolve: 2024-10-15 Ultrasound Probe - Non-Glass Falcon - CE
• 10841911102769 - Mammotome revolve: 2024-10-15 Ultrasound Probe - Non-Glass Falcon - CE
• 00841911103530 - HydroMARK: 2024-09-27 HydroMARK Breast Biopsy Site Marker- CE
• 00841911102526 - neoprobe: 2024-09-24 Bluetooth Straight Probe, Model 1100 - CE