| Primary Device ID | 00860457001513 |
| NIH Device Record Key | b02f8175-b898-437c-86fa-6171a530b37a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ablacath Catheter Extension Cable |
| Version Model Number | AB-0004 |
| Company DUNS | 106083214 |
| Company Name | Ablacon Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860457001513 [Primary] |
| IKD | Cable, Electrode |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860457001513]
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
[00860457001513]
Ethylene Oxide
[00860457001513]
Ethylene Oxide
[00860457001513]
Ethylene Oxide
[00860457001513]
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Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-03 |
| Device Publish Date | 2025-02-21 |
| 00860457001513 - Ablacath Catheter Extension Cable | 2025-03-03Catheter extension cable |
| 00860457001513 - Ablacath Catheter Extension Cable | 2025-03-03 Catheter extension cable |
| 00860457001520 - Ablacath System Interconnect Cable | 2025-03-03 System interconnect cable |
| 00860457001544 - Ablacon™ Mapping Catheter | 2023-12-15 The Ablacath™ Mapping Catheter may be used to detect electrical potentials from the endocardial surfaces of the heart. These |
| 00860457001551 - Ablacon™ Mapping Catheter | 2023-12-15 The Ablacath™ Mapping Catheter may be used to detect electrical potentials from the endocardial surfaces of the heart. These |
| 00860457001568 - Ablamap® System | 2023-12-15 The Ablamap® System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The s |