Invivo
GUDID 00884838086401
dS Small Extremity 16Ch 1.5T
INVIVO CORPORATION
MRI system coil, radio-frequency| Primary Device ID | 00884838086401 |
| NIH Device Record Key | 4f22075a-3aab-4142-b80d-448696401af2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invivo |
| Version Model Number | 45980129110 |
| 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 Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 70 KiloPascal and 110 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 | 00884838086401 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162863
FDA Product Code
| MOS | Coil, magnetic resonance, specialty |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2019-02-28 |
On-Brand Devices [Invivo]
| 00884838087408 | dS Small Extremity 16Ch 3.0T |
| 00884838087347 | 4ch SENSE Shoulder Coil 3.0T |
| 00884838087323 | 8 Channel High Resolution Brain Coil |
| 00884838087316 | Precision Eight Wrist Array |
| 00884838087231 | Precision Eight Wrist Array |
| 00884838087002 | dS HiRes Hand/Wrist 16Ch 3.0T |
| 00884838086630 | DynaCAD 4.0 System |
| 00884838086425 | dS Breast 16ch 1.5T |
| 00884838086401 | dS Small Extremity 16Ch 1.5T |
| 00884838086395 | dS Head 32ch 3.0T |
| 00884838086388 | dS FootAnkle 16Ch 3.0T |
| 00884838086371 | dS FootAnkle 16Ch 1.5T |
| 00884838086357 | dS Shoulder 16Ch 3.0T |
| 00884838086340 | dS Shoulder 16Ch 1.5T |
| 00884838086326 | dS Breast Adaptive 16CH 3.0T |
| 00884838086302 | dS Breast Adaptive 16CH 1.5T |
| 00884838086296 | dS Shoulder 8ch 3.0T |
| 00884838086272 | dS Knee 16Ch 1.5T |
| 00884838086265 | dS SmallExtr 8ch 3.0T |
| 00884838086241 | dS SmallExtr 8ch 1.5T |
| 00884838086234 | dS Shoulder 8ch 1.5T |
| 00884838086227 | dS FootAnkle 8Ch 3.0T |
| 00884838086203 | dS WRIST 8CH 3.0T |
| 00884838086197 | dS Breast 16ch 3.0T |
| 00884838086173 | dS Breast 7ch 3.0T |
| 00884838086166 | dS Knee 8Ch 3.0T |
| 00884838086159 | dS HiRes Hand/Wrist 16Ch 1.5T |
| 00884838086142 | dS FootAnkle 8Ch 1.5T |
| 00884838086135 | dS Wrist 8Ch 1.5T |
| 00884838086128 | dS Knee 8Ch 1.5T |
| 00884838086111 | dS Breast 7ch 1.5T |
| 00884838086104 | dS T/R Knee 16ch 3.0T |
| 00884838086098 | dS HeadNeck 3.0T |
| 00884838086081 | dS HeadNeck 1.5T |
| 00884838086074 | dS Head 3.0T |
| 00884838086067 | dS Head 1.5T |
| 00884838086050 | dS Base 3.0T |
| 00884838086043 | dS Base 1.5T |
| 00884838086036 | dS Anterior 3.0T |
| 00884838086029 | dS Anterior 1.5T |
| 00884838085916 | dS Anterior for HIFU, 3.0T |
| 00884838085749 | Small Extremity Array Coil |
| 00884838085510 | DynaLync Prostate |
| 00884838084537 | Breast MRI 8ch Table for GE 1.5T |
| 00884838084414 | Lateral Grid, Upper dS Breast 16ch I/T |
| 00884838084407 | Lateral Grid, Lower Breast dS 16ch I/T |
| 00884838083813 | 2 Channel Endo Coil Array for Siemens 3T |
| 00884838083806 | 2 Channel Endo Coil Array for Siemens 1.5T |
| 00884838083615 | Biopsy Grid (User-sterilized) |
| 00884838083608 | Biopsy Grid |
Trademark Results [Invivo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INVIVO 85260514 4445850 Live/Registered |
InViVo Communications, Inc. 2011-03-08 |
 INVIVO 79286963 not registered Live/Pending |
UNION INVIVO 2019-12-10 |
 INVIVO 79226115 5841568 Live/Registered |
Koninklijke Philips N.V. 2017-07-28 |
 INVIVO 79212360 5567595 Live/Registered |
Koninklijke Philips N.V. 2017-04-05 |
 INVIVO 79179747 4943827 Live/Registered |
INVIVO & CO LIMITED 2015-07-06 |
 INVIVO 78777786 not registered Dead/Abandoned |
LOUBATON VIVO 2005-12-21 |
 INVIVO 78503798 3178707 Dead/Cancelled |
Invivo Corporation 2004-10-21 |
 INVIVO 77341538 not registered Dead/Abandoned |
9171-2349 Québec Inc. 2007-11-30 |
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