| Primary Device ID | 10884521198722 |
| NIH Device Record Key | e2cb9c71-4562-4d22-ad35-ba9f8a75a00b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | superDimension |
| Version Model Number | AKI00131-01 |
| Catalog Number | AKI00131-01 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 60 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| covidien.udi@covidien.com | |
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| covidien.udi@covidien.com | |
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| covidien.udi@covidien.com | |
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| covidien.udi@covidien.com | |
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| covidien.udi@covidien.com | |
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| covidien.udi@covidien.com | |
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| covidien.udi@covidien.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521198722 [Primary] |
| GS1 | 10884521713086 [Unit of Use] |
| GS1 | 20884521807973 [Unit of Use] |
| JAK | System, x-ray, tomography, computed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-09-24 |
| 20884521200514 | Pre-Marked Biopsy Forceps |
| 20884521200484 | Biopsy Forceps |
| 20884521198804 | Fiducial Marker;3-Band |
| 20884521198781 | Fiducial Marker;Coil |
| 20884521198774 | Fiducial Marker;Coil |
| 20884521197708 | Fiducial Marker;Coil |
| 10884521198722 | Patient Sensor Patch |
| 10884521785861 | superDimension Planning Station |
| 10884521806153 | navigation system console |
| 10884521582835 | Planning Station |
| 10884521545588 | Planning Station |
| 10884521200364 | iLogic inReach;Planning Laptop |
| 20884521200477 | Aspirating Needle |
| 20884521200552 | Triple Needle Cytology Brush;15 mm |
| 20884521200545 | Triple Needle Cytology Brush;10 mm |
| 20884521200521 | Marker Delivery Kit |
| 20884521200507 | Pre-marked Aspirating Needle |
| 20884521200491 | Pre-marked Aspirating Needle |
| 20884521809472 | Aspirating Needle |
| 20884521809519 | Pre-marked Aspirating Needle |
| 20884521809588 | Triple Needle Cytology Brush;15 mm |
| 20884521809571 | Triple Needle Cytology Brush;10 mm |
| 20884521809540 | Pre-Marked Biopsy Forceps |
| 20884521809526 | Pre-marked Aspirating Needle |
| 20884521809564 | Marker Delivery Kit |
| 20884521807973 | Patient Sensor Patch |
| 10884521747418 | v7.2 upgrade kit |
| 10884521199989 | Navigation System |
| 10884521747432 | v7.1 Planning Software |
| 10884521747425 | v7.2 Procedure Software |
| 20884521200538 | Needle-tipped Cytology Brush; Aspirating Port |
| 20884521200460 | Cytology Brush |
| 20884521198798 | Fiducial Marker;2-Band |
| 20884521843216 | Needle-tipped Cytology Brush Aspirating Port |
| 20884521843209 | Pre-marked Aspirating Needle |
| 20884521843193 | Pre-marked Aspirating Needle |
| 20884521843186 | Aspirating Needle |
| 20884521843179 | Cytology Brush |
| 10884521199996 | Navigation System |
| 20884521852195 | superDimension Marker Delivery Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUPERDIMENSION 76139192 2971029 Live/Registered |
COVIDIEN LP 2000-10-03 |