Mammotome elite
GUDID 00841911101703
"Holster (tetherless vacuum-assisted biopsy system)"
DEVICOR MEDICAL PRODUCTS, INC.
Mammographic stereotactic biopsy system| Primary Device ID | 00841911101703 |
| NIH Device Record Key | 8025295c-a042-43ef-b87e-5e51d90b59c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mammotome elite |
| Version Model Number | MEH1 |
| 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
| 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
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 -20 Degrees Celsius and 50 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 | 00841911101703 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153709
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 | 2022-02-15 |
| Device Publish Date | 2022-02-07 |
On-Brand Devices [Mammotome elite]
| 10841911100895 | Probe |
| 10841911100888 | Probe |
| 00841911100850 | Holster (tetherless vacuum-assisted biopsy system) |
| 10841911100871 | Introducer Stylet |
| 10841911100864 | Introducer Stylet |
| 00841911101703 | "Holster (tetherless vacuum-assisted biopsy system)" |
| 00841911102823 | Holster (tetherless vacuum-assisted biopsy system) |
| 10841911102806 | Probe |
| 10841911102790 | Mammotome Elite Probe |
Trademark Results [Mammotome elite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMOTOME ELITE 85782899 4364699 Live/Registered |
Devicor Medical Products, Inc. 2012-11-19 |
 MAMMOTOME ELITE 85320701 4203206 Live/Registered |
Devicor Medical Products, Inc. 2011-05-13 |
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