Mammotome
GUDID 00841911100621
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DEVICOR MEDICAL PRODUCTS, INC.
Mammographic stereotactic biopsy system| Primary Device ID | 00841911100621 |
| NIH Device Record Key | ef04f1da-b888-4198-b15e-9b423fc81fdb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mammotome |
| Version Model Number | SCMC3 |
| 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 | false |
| 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
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com | |
| Phone | 877-926-2666 |
| customersupport@mammotome.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -35 Degrees Celsius and 54 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841911100621 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042753
FDA Product Code
| KNW | Instrument, Biopsy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-10 |
On-Brand Devices [Mammotome]
| 10841911101281 | DISPOSABLE DRAPE |
| 10841911101229 | Vacuum Set |
| 10841911100994 | Hand-Held Probe |
| 10841911100987 | Hand-Held Probe |
| 10841911100970 | Hand-Held Probe |
| 10841911100963 | Hand-Held Probe |
| 00841911100645 | Holster and Cable |
| 00841911100638 | Software Package |
| 00841911100621 | Cart Upgrade |
| 00841911100614 | Cart |
| 00841911100607 | Control Module with SmartVac |
| 00841911100591 | Control Module with SmartVac |
| 00841911100584 | Control Module MR Interlock System |
| 00841911100577 | Holster with Keypad, Spool and Cable |
| 00841911100560 | Remote Keypad |
| 00841911100553 | Footswitch |
| 00841911100546 | Holster and Cable |
| 10841911101243 | Variable Aperture Sleeve |
| 10841911101236 | Variable Aperture Sleeve |
| 10841911101199 | Probe Guide |
| 10841911101182 | Probe Guide |
| 10841911101175 | Localization Guide |
| 10841911101168 | Probe Guide |
| 10841911101151 | Probe Guide |
| 10841911101144 | Probe Guide |
| 10841911101137 | Probe Guide |
| 10841911101120 | Probe Guide |
| 00841911101888 | Control Module MR Interlock System |
| 00841911101765 | Footswitch |
| 00841911101840 | Holster and Cable |
| 00841911101833 | Software Package |
| 00841911101826 | Cart Upgrade |
| 00841911101819 | Cart |
| 00841911101802 | Control Module with SmartVac |
| 00841911101796 | Control Module with SmartVac |
Trademark Results [Mammotome]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMOTOME 74573480 1971904 Live/Registered |
DEVICOR MEDICAL PRODUCTS, INC. 1994-09-14 |
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