| Primary Device ID | 00685447000969 |
| NIH Device Record Key | 9f6a6dbb-f64f-4c6c-9d58-3a5ec5563279 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Baylis Medical Company Radiofrequency Puncture Generator |
| Version Model Number | RFP-100A |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | 00685447000969 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-15 |
| 00685447020080 - VersaCross Connect™ | 2024-08-28 Access Solution for CARTO VIZIGO™ Sheath |
| 00685447020103 - VersaCross Connect™ | 2024-08-28 Access Solution for CARTO VIZIGO™ Sheath |
| 00685447019046 - VersaCross Connect Access Solution for FARADRIVE | 2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use)) |
| 00685447019053 - VersaCross Connect Access Solution for FARADRIVE | 2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use)) |
| 00685447019060 - VersaCross Connect Access Solution for FARADRIVE | 2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use)) |
| 00685447019077 - VersaCross Connect Access Solution for FARADRIVE | 2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use)) |
| 00685447005964 - SupraCross Steerable Sheath | 2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447005971 - SupraCross Steerable Sheath | 2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |