| Primary Device ID | 00685447005612 |
| NIH Device Record Key | 2c19d307-e73d-4586-bdac-8b4fa0fc8075 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SupraCross Steerable Sheath |
| Version Model Number | SSS0005 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00685447005612 [Primary] |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-27 |
| Device Publish Date | 2021-04-19 |
| 00685447002574 | SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447002567 | SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447002550 | SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447001669 | SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447001270 | SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447005629 | SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447005612 | SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447005605 | SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447005988 | SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447005971 | SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |
| 00685447005964 | SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire |