| Primary Device ID | 00840663106837 | 
| NIH Device Record Key | 2c3002d1-9b7e-4eee-a580-50334f655095 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Hydro LeMaitre Valvulotome | 
| Version Model Number | e1010-00 | 
| Catalog Number | e1010-00 | 
| 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 | 00840663106837 [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) |