Mammotome revolve
GUDID 00841911101895
Stereotactic Holster
DEVICOR MEDICAL PRODUCTS, INC.
Mammographic stereotactic biopsy system| Primary Device ID | 00841911101895 |
| NIH Device Record Key | 3bf97b95-5938-409c-bdbb-cc25c33b94f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mammotome revolve |
| Version Model Number | MSTH1 |
| 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 | 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 |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841911101895 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152989
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 | 2022-02-16 |
| Device Publish Date | 2022-02-08 |
On-Brand Devices [Mammotome revolve]
| 10841911100826 | Ultrasound Probe |
| 10841911100819 | Ultrasound Probe |
| 10841911100765 | Stereotactic Probe |
| 10841911100758 | Stereotactic Probe |
| 10841911100741 | Stereotactic Probe |
| 10841911100734 | Stereotactic Probe |
| 10841911100727 | Stereotactic Probe |
| 10841911100710 | Stereotactic Probe |
| 00841911100706 | Stereotactic Holster |
| 00841911100690 | Control Module |
| 00841911100683 | Ultrasound Holster |
| 00841911100676 | Remote Keypad |
| 00841911100669 | Footswitch |
| 00841911100652 | Cart |
| 10841911100802 | Probe Guide |
| 10841911100796 | Probe Guide |
| 10841911100789 | Probe Guide |
| 10841911100772 | Probe Guide |
| 10841911102615 | Stereotactic Probe |
| 10841911102608 | Stereotactic Probe |
| 10841911102592 | Stereotactic Probe |
| 10841911102585 | Stereotactic Probe |
| 10841911102578 | Stereotactic Probe |
| 10841911102561 | Stereotactic Probe |
| 00841911102267 | Control Module |
| 00841911102045 | Ultrasound Holster |
| 00841911101895 | Stereotactic Holster |
| 00841911101871 | Remote Keypad |
| 00841911101864 | Footswitch |
| 00841911102328 | Control Module Revolve EX |
| 10841911102721 | Stereotactic Probe - Non-Glass Falcon - CE |
| 10841911102714 | Stereotactic Probe - Non-Glass Falcon - CE |
| 10841911102707 | Stereotactic Probe - Non-Glass Falcon - CE |
| 00841911102694 | Stereotactic Probe - Non-Glass Falcon - CE |
| 00841911103165 | Mammotome Revolve Control Module |
| 10841911102769 | Ultrasound Probe - Non-Glass Falcon - CE |
| 10841911102752 | Ultrasound Probe - Non-Glass Falcon - CE |
| 10841911102745 | Stereotactic Probe - Non-Glass Falcon - CE |
| 00841911102731 | Stereotactic Probe - Non-Glass Falcon - CE |
| 10841911102356 | Revolve EX Ultrasound 8G Probe without Sleeve - CE |
Trademark Results [Mammotome revolve]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMOTOME REVOLVE 85782986 4364706 Live/Registered |
Devicor Medical Products, Inc. 2012-11-19 |
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