| Primary Device ID | 04573596210611 |
| NIH Device Record Key | f80c0788-70d5-46aa-9ab3-c17b43fc7bdf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MP-2794-G16 |
| Version Model Number | MP-2794-G16 |
| Company DUNS | 718262719 |
| Company Name | FUJIFILM HEALTHCARE CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Needle Gauge | 16 Gauge |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04562122957366 [Previous] |
| GS1 | 04573596210611 [Primary] |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| OIJ | Biopsy Needle Guide Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
[04573596210611]
Ethylene Oxide;High-level Disinfectant
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-26 |
| Device Publish Date | 2021-07-18 |
| 04573596204382 - FUJIFILM | 2024-07-22 |
| 04573596212011 - L31KP | 2024-02-02 Probe |
| 04573596212318 - S3ESCLS | 2024-02-02 Probe |
| 04573596212035 - L35 | 2024-01-30 Probe |
| 04573596212455 - UST-2266-5 | 2024-01-30 Probe |
| 04573596214176 - CL4416R1 | 2024-01-30 Probe |
| 04573596214336 - C421 | 2024-01-30 Probe |
| 04573596214503 - CC41R2 | 2024-01-30 Probe |