| Primary Device ID | 38718122013985 |
| NIH Device Record Key | d0b09548-d9f3-4fd9-bc7d-e178de30501e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Primum Guiding Catheter |
| Version Model Number | 6F Primum JR4 |
| Catalog Number | 26102804 |
| Company DUNS | 413008652 |
| Company Name | PendraCare International B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08718122013984 [Primary] |
| GS1 | 38718122013985 [Package] Contains: 08718122013984 Package: [5 Units] In Commercial Distribution |
| 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 | 2026-02-10 |
| Device Publish Date | 2026-02-02 |
| 38718122028897 | The Hydrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of i |
| 38718122013985 | The Hdrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of in |
| 08718122013915 | The Hdrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of in |