| Primary Device ID | B09921005600 |
| NIH Device Record Key | bef800fd-6f07-4a7d-897c-1058f0284392 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROFUNDA DEBAKEY CLAMP |
| Version Model Number | 2100-560 |
| 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 | |
| Phone | 800-821-7496 |
| info@sontecinstruments.com |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896076631 [Primary] |
| HIBCC | B09921005600 [Previous] |
| DXC | Clamp, Vascular |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B09921005600]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09921005600]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09921005600]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-08-21 |
| Device Publish Date | 2018-08-23 |
| B09921005600 | PROFUNDA DEBAKEY CLAMP ANGLED CURVED JAW ANGLED CURVED SHANK ANGLED BACKWARD |
| B09921005620 | PROFUNDA DEBAKEY CLAMP ANGLED CURVED JAW/SHANK ANGLED BACKWARD |
| B09921005640 | PROFUNDA DEBAKEY CLAMP ANGLED CURVED JAW/SHANK ANGLED BACKWARD |