| Primary Device ID | 50732224002908 |
| NIH Device Record Key | cf4e27de-b7de-4e94-ac3c-03d7f1297b4c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sani ProZyme Enzymatic Detergent |
| Version Model Number | JED |
| Catalog Number | JED |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732224002903 [Primary] |
| GS1 | 50732224002908 [Package] Contains: 00732224002903 Package: [4 Units] In Commercial Distribution |
| FLG | Cleaner, ultrasonic, medical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-18 |
| Device Publish Date | 2023-08-10 |
| 00732224005690 - Crosstex | 2024-04-29 Soft Adaptors for Hygoformic Saliva Ejectors |
| 00732224721484 - Sporview 10 Hour Self Contained BI | 2024-04-18 For use in biologically monitoring steam sterilizers |
| 20815878025321 - Burkhart Non-Woven Sponges | 2024-04-17 |
| 20815878027585 - Burkhart Non-Woven Sponges | 2024-04-17 |
| 20815878027592 - Burkhart Cotton Rolls | 2024-04-17 |
| 20815878028483 - Burkhart Non-Woven Sponges | 2024-04-17 |
| 10732224005673 - DentaPure Water Purification Bottle Cartridge | 2024-04-16 International Water Purification Bottle Cartridge |
| 10732224005680 - DentaPure Water Purification Municipal Cartridge | 2024-04-16 International Water Purification Municipal Cartridge |