| Primary Device ID | 00840663101283 | 
| NIH Device Record Key | 8375df58-0971-4291-88d0-3dd38e947c16 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Pruitt F3 Carotid Shunt | 
| Version Model Number | e2012-10 | 
| Catalog Number | e2012-10 | 
| 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 | true | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | |
| Phone | 781-221-2266 | 
| xx@xx.xx | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840663101283 [Primary] | 
| MJN | Catheter, Intravascular Occluding, Temporary | 
| 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 | 2015-06-30 | 
| 00840663101320 | 8F Pruitt F3 Outlying Shunt with T-port, eIFU | 
| 00840663101313 | 9F Pruitt F3 Inlying Shunt without T-port, eIFU | 
| 00840663101306 | 9F Pruitt F3 Inlying Shunt with T-port, eIFU | 
| 00840663101290 | 9F Pruitt F3 Outlying Shunt without T-port, eIFU | 
| 00840663101283 | 9F Pruitt F3 Outlying Shunt with T-port, eIFU | 
| 00840663101276 | 10F Pruitt F3 inlying Shunt with T-port, eIFU | 
| 00840663101269 | 10F Pruitt F3 Outlying Shunt with T-port, eIFU | 
| 00840663101252 | 8F Pruitt F3 Outlying Shunt with T-port | 
| 00840663101245 | 9F Pruitt F3 Inlying Shunt without T-port | 
| 00840663101238 | 9F Pruitt F3 Inlying Shunt with T-port | 
| 00840663101221 | 9F Pruitt F3 Outlying Shunt without T-port | 
| 00840663101214 | 9F Pruitt F3 Outlying Shunt with T-port | 
| 00840663101207 | 10F Pruitt F3 inlying Shunt with T-port | 
| 00840663101191 | 10F Pruitt F3 Outlying Shunt with T-port |