| Primary Device ID | 00685447020226 | 
| NIH Device Record Key | ca8e1b27-01fa-45cb-af4f-cd62fdf78311 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | VersaCross™ Steerable Sheath | 
| Version Model Number | VST0202 | 
| Catalog Number | VST0202 | 
| 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 | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 00685447020226 [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 | 2025-03-05 | 
| Device Publish Date | 2025-02-25 | 
| 00685447020257 | Steerable Sheath | 
| 00685447020240 | Steerable Sheath | 
| 00685447020233 | Steerable Sheath | 
| 00685447020226 | Steerable Sheath | 
| 00685447020219 | Steerable Sheath | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  VERSACROSS  90333192  not registered Live/Pending | Baylis Medical Company Inc. 2020-11-20 | 
|  VERSACROSS  86908879  5851875 Live/Registered | Baylis Medical Company Inc. 2016-02-16 | 
|  VERSACROSS  76689672  3625044 Live/Registered | BALTIMORE AIRCOIL COMPANY, INC. 2008-05-15 |