| Primary Device ID | 00685447013891 |
| NIH Device Record Key | 709d0d16-78ac-4918-afa0-e95bf9c1ec5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NRG RF Transseptal Kit |
| Version Model Number | NTK-P711-8545 |
| Company DUNS | 249225954 |
| Company Name | Baylis Médicale Cie 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 | true |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00685447013891 [Primary] |
| DXF | Catheter, Septostomy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-08 |
| Device Publish Date | 2022-07-29 |
| 00685447002932 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002925 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002918 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002901 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002895 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002888 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002871 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002864 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002857 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002840 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002833 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002826 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode |
| 00685447002819 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002802 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002796 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002789 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002772 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002765 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002758 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002741 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002734 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002727 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002710 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002703 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002697 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002680 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002673 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002666 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002659 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002642 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002635 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002628 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002611 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002604 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002598 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447002581 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001591 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001584 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001577 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001560 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001553 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001546 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001539 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001522 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001515 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001508 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001492 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001485 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001478 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |
| 00685447001461 | 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 |