| Primary Device ID | 00840663106820 |
| NIH Device Record Key | 4443e363-341c-427b-a045-c3fc59a96b6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hydro LeMaitre Valvulotome |
| Version Model Number | e1009-00 |
| Catalog Number | e1009-00 |
| Company DUNS | 184805166 |
| Company Name | LEMAITRE VASCULAR, 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 |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840663106820 [Primary] |
| MGZ | Valvulotome |
| 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 | 2015-07-15 |
| 00840663106837 | Hydro LeMaitre Valvulotome (40 cm), eIFU |
| 00840663106820 | Hydro LeMaitre Valvulotome (98 cm), eIFU |
| 00840663106660 | 1.5mm HYDRO LeMaitre Valvulotome (40 cm) |
| 00840663106653 | 1.5mm HYDRO LeMaitre Valvulotome (98 cm) |