| Primary Device ID | B09928007822L0 |
| NIH Device Record Key | a3faaf6d-7ab4-4b54-be7b-e25940efe526 |
| Commercial Distribution Discontinuation | 2018-06-22 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | HEARTLINE DEBAKEY GRASPER |
| Version Model Number | 2800-7822L |
| Company DUNS | 040729840 |
| Company Name | SONTEC INSTRUMENTS, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-821-7496 |
| info@sontecinstruments.com | |
| Phone | 800-821-7496 |
| info@sontecinstruments.com |
| Length | 29 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 29 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B09928007822L0 [Primary] |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B09928007822L0]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928007822L0]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-19 |
| 00192896045712 | HEARTLINE DEBAKEY GRASPER STRAIGHT TIP |
| B099280078270 | HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT |
| B099280078240 | HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT |
| B099280078230 | HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT |
| B099280078220 | HEARTLINE DEBAKEY GRASPER CURVED TO SIDE 1x2 JAW |
| B09928007821S0 | HEARTLINE DEBAKEY GRASPER 1x2 CURVED UP JAW |
| B099280078210 | HEARTLINE DEBAKEY GRASPER 1x2 CURVED UP JAW |
| B09928007820S0 | HEARTLINE DEBAKEY GRASPER 1x2 STRAIGHT JAW |
| B09928007820L0 | HEARTLINE DEBAKEY GRASPER 1x2 STRAIGHT JAW |
| B099280078200 | HEARTLINE DEBAKEY GRASPER 1x2 STRAIGHT JAW |
| B0992800341S0 | HEARTLINE DEBAKEY GRASPER 2x3 JAW SQUEEZE HANDLE |
| B09928003410 | HEARTLINE DEBAKEY GRASPER 2x3 JAW SQUEEZE HANDLE |
| B0992800340S0 | HEARTLINE DEBAKEY GRASPER 1x2 JAW SQUEEZE HANDLE |
| B09928003400 | HEARTLINE DEBAKEY GRASPER SQUEEZE HANDLE |
| B09928007827S0 | HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT |
| B09928007827L0 | HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT |
| B09928007824S0 | HEARTLINE DEBAKEY GRASPER STRAIGHT |
| B09928007824L0 | HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT |
| B09928007823S0 | HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT |
| B09928007823L0 | HEARTLINE DEBAKEY GRASPER STRAIGHT 1X2 JAW STRAIGHT |
| B09928007822S0 | HEARTLINE DEBAKEY GRASPER CURVED TO SIDE 1x2 JAW |
| B09928007822L0 | HEARTLINE DEBAKEY GRASPER CURVED TO SIDE 1x2 JAW |
| B09928007821L0 | HEARTLINE DEBAKEY GRASPER 1x2 CURVED UP JAW |
| B0992800341L0 | HEARTLINE DEBAKEY GRASPER 2x3 JAW SQUEEZE HANDLE |
| B0992800340L0 | HEARTLINE DEBAKEY GRASPER 1X2 JAW SQUEEZE HANDLE |
| 00192896114579 | Heartline Debakey Grasper Straight 1.5 x 23 Millimeter Jaw |
| 00192896117655 | Heartline Debakey Grasper 2.8 x 15 Millimeter Jaw Squeeze Handle |
| 00192896121997 | Heartline Debakey Grasper Tungsten Carbide Jaw Squeeze Handle |