Sentinelle
GUDID 00884838105294
dS 1.5T 4CH Lateral Left
INVIVO CORPORATION
MRI system coil, radio-frequency| Primary Device ID | 00884838105294 |
| NIH Device Record Key | 946591a3-3e4d-4be9-9328-ed9a1e468211 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sentinelle |
| Version Model Number | 4598-017-21691 |
| Company DUNS | 009237140 |
| Company Name | INVIVO CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1100 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838105294 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213735
FDA Product Code
| MOS | Coil, Magnetic Resonance, Specialty |
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 | 2022-10-04 |
| Device Publish Date | 2022-09-26 |
On-Brand Devices [Sentinelle]
| 00884838105348 | dS 1.5T Medial Plug |
| 00884838105324 | dS Patient Support |
| 00884838105317 | dS Headrest |
| 00884838105294 | dS 1.5T 4CH Lateral Left |
| 00884838105287 | dS 1.5T 1CH Lateral Right |
| 00884838105270 | dS 1.5T 1CH Lateral Left |
| 00884838105263 | dS 1.5T 8CH Medial |
| 00884838105256 | dS 1.5T 4CH Lateral Right |
| 00884838105249 | dS 1.5T Interface Box |
| 00884838105300 | dS 3.0T Interface Box |
| 00884838105331 | dS 3.0T Medial Plug |
| 00884838105232 | dS 3.0T 1CH Lateral Right |
| 00884838105225 | dS 3.0T 1CH Lateral Left |
| 00884838105218 | dS 3.0T 8CH Medial |
| 00884838105201 | dS 3.0T 4CH Lateral Right |
| 00884838105195 | dS 3.0T 4CH Lateral Left |
| 00884838115514 | DS Sentinelle Breast coil, Biopsy Kit 3.0T Consists of 1CH Left and Right Lateral Coils and Medi |
| 00884838115507 | DS Sentinelle Breast 16CH Coil Kit, 1.5T Consists of 1CH Left and Right Lateral Coils and Medial |
| 00884838103740 | Sentinelle, Biopsy Grid |
Trademark Results [Sentinelle]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENTINELLE 85125786 4440525 Live/Registered |
INVIVO CORPORATION 2010-09-09 |
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