| Primary Device ID | 20884521843216 | 
| NIH Device Record Key | 37c5850e-245f-4d1d-8509-77f9e70e5087 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | superDimension | 
| Version Model Number | SDNB2000 | 
| Company DUNS | 058614483 | 
| Company Name | Covidien LP | 
| 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 | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10884521843219 [Primary] | 
| GS1 | 20884521843216 [Package] Contains: 10884521843219 Package: CASE [10 Units] In Commercial Distribution | 
| FDX | endoscopic cytology brush | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-07-31 | 
| Device Publish Date | 2023-07-22 | 
| 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 |