| Primary Device ID | 00685447002116 |
| NIH Device Record Key | 9049895b-8fa1-4360-9693-b310b45a0974 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AnchorKnot Suture Cutter (2-0) |
| Version Model Number | PSZ-400-308 |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00685447002116 [Primary] |
| HRX | Arthroscope |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-06-16 |
| 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 |
| 00685447005988 - SupraCross Steerable Sheath | 2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447006213 - SureFlex Steerable Guiding Sheath | 2023-11-16 SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |