| Primary Device ID | B09921006280 |
| NIH Device Record Key | b1b8d06c-39ac-4a2d-a728-891f873bd178 |
| Commercial Distribution Discontinuation | 2018-06-22 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | DEBAKEY COARCTATION CLAMP |
| Version Model Number | 2100-628 |
| 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 | 7 Inch |
| Length | 7 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B09921006280 [Primary] |
| DXC | Clamp, Vascular |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B09921006280]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09921006280]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-19 |
| B09921006340 | DEBAKEY COARCTATION CLAMP STRAIGHT JAW ANGLED SHANK |
| B09921006300 | DEBAKEY COARCTATION CLAMP STRAIGHT |
| B09921006270 | DEBAKEY COARCTATION CLAMP WITH INTERLOCKING BECK SERRATION SPOON JAW |
| B09921006280 | DEBAKEY COARCTATION CLAMP SLIGHT SPOON JAW |
| B09921006260 | DEBAKEY COARCTATION CLAMP STRAIGHT JAW CURVED SHANK |
| B09921006220 | DEBAKEY COARCTATION CLAMP STRAIGHT |
| 00192896071131 | DEBAKEY COARCTATION CLAMP STRAIGHT TIP |