| Primary Device ID | 00685447012405 |
| NIH Device Record Key | a8ff7df4-48e8-42a0-b52e-769f036a3a22 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VersaCross Large Access Solution |
| Version Model Number | VLAK0001 |
| Catalog Number | NA |
| 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 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00685447012405 [Primary] |
| DXF | Catheter, Septostomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-19 |
| Device Publish Date | 2022-07-11 |
| 00685447006916 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006909 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006879 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006862 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006831 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006824 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006794 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006787 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006930 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006923 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006893 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006886 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006855 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006848 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006817 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447006800 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012559 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012542 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012535 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012528 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012511 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012504 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012498 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012481 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012474 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012467 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012450 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012443 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012436 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012429 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012412 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447012405 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017592 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017585 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017578 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017561 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017554 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017547 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017530 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017523 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017516 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017509 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017493 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017486 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017479 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017462 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017455 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |
| 00685447017448 | 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x |