| Primary Device ID | 08500320790077 | 
| NIH Device Record Key | 6efdf4d6-21de-47d5-b123-b3fa3e2f19f4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Prodigy™ Catheter | 
| Version Model Number | PRODIGY8F-S | 
| Catalog Number | PRODIGY8F-S | 
| Company DUNS | 104006631 | 
| Company Name | Truvic Medical, Inc. | 
| 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 | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Catheter Length | 50 Centimeter | 
| Catheter Inner Diameter | 0.088 Inch | 
| Outer Diameter | 0.11 Inch | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08500320790077 [Primary] | 
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-04-26 | 
| Device Publish Date | 2022-04-18 | 
| 08500320790077 | 8F Short Prodigy™ Catheter Length: 50 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2. | 
| 08500320790060 | 8F Prodigy™ Catheter Length: 90 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2.80 mm) | 
| 08500320790053 | 6F Prodigy™ Catheter Length: 137 cm Inner Diameter: 0.071 in Outer Diameter: 0.085 in (2.13 mm | 
| 08500320790046 | 5F Prodigy™ Catheter Length: 160 cm Inner Diameter: 0.055 in Outer Diameter: 0.067 in (1.70 mm | 
| 00850032079075 | 8F Short Prodigy™ Catheter Length: 50 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2. | 
| 00850032079068 | 8F Prodigy™ Catheter Length: 90 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2.80 mm) | 
| 00850032079051 | 6F Prodigy™ Catheter Length: 137 cm Inner Diameter: 0.071 in Outer Diameter: 0.085 in (2.13 m | 
| 00850032079044 | 5F Prodigy™ Catheter Length: 160 cm Inner Diameter: 0.055 in Outer Diameter: 0.067 in (1.70 m | 
| 00850032079143 | 8F Prodigy™ Catheter Length: 117 cm Inner Diameter: 2.2 mm Outer Diameter: 2.8 mm |