| Primary Device ID | 00192896009349 |
| NIH Device Record Key | 08343ae6-8c85-4491-9f9a-5b47731392b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FREEZE POINT DEVICE |
| Version Model Number | CRY16-2 |
| Catalog Number | CRY16-2 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896009349 [Primary] |
| GEH | Unit, Cryosurgical, Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896009349]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896009349]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896009349]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-17 |
| Device Publish Date | 2018-08-15 |
| 00192896009349 | FREEZE POINT DEVICE |
| 00192896009332 | FREEZE POINT DEVICE |