| Primary Device ID | 10860013404410 |
| NIH Device Record Key | 1eaa4300-f91b-4dcc-97f7-3dea638dc1f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shadow Catheter(TM) |
| Version Model Number | FG 01409 |
| Catalog Number | FG 01409 |
| Company DUNS | 118254616 |
| Company Name | Simpson Interventions, Inc. |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10860013404410 [Primary] |
| DQY | Catheter, Percutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-06 |
| Device Publish Date | 2025-02-26 |