| Primary Device ID | B09928007819L0 |
| NIH Device Record Key | bae60a9a-2abd-4515-8444-3b8d06fbd3d9 |
| Commercial Distribution Discontinuation | 2018-06-22 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | HEARTLINE TUNGSTEN CARBIDE DEBAKEY GRASPER |
| Version Model Number | 2800-7819L |
| 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 | 29.2 Centimeter |
| Device Size Text, specify | 0 |
| Length | 29.2 Centimeter |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B09928007819L0 [Primary] |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B09928007819L0]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928007819L0]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-19 |
| B09928007819S0 | HEARTLINE TUNGSTEN CARBIDE DEBAKEY GRASPER |
| B099280078190 | HEARTLINE TUNGSTEN CARBIDE DEBAKEY GRASPER |
| B09928007819L0 | HEARTLINE TUNGSTEN CARBIDE DEBAKEY GRASPER |