| Primary Device ID | 00840663101191 |
| NIH Device Record Key | 05553fe4-1519-46a9-987f-84dfd0a6878b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pruitt F3 Carotid Shunt |
| Version Model Number | 2011-10 |
| Catalog Number | 2011-10 |
| 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 | 00840663101191 [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 |