| Primary Device ID | B09927002660 |
| NIH Device Record Key | e6b609a6-d356-41d4-9c7a-26cdda3a46cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SARNS MYOCARDIAL DILATOR |
| Version Model Number | 2700-266 |
| 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 | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896005976 [Primary] |
| HIBCC | B09927002660 [Previous] |
| DWP | Dilator, Vessel, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B09927002660]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09927002660]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09927002660]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-21 |
| Device Publish Date | 2018-08-21 |
| B09927002660 | SARNS MYOCARDIAL DILATOR |
| B09927002640 | SARNS MYOCARDIAL DILATOR |
| B09927002620 | SARNS MYOCARDIAL DILATOR |
| B09927002600 | SARNS MYOCARDIAL DILATOR |