| Primary Device ID | 00660483130597 | 
| NIH Device Record Key | 745f8089-0d5a-434c-8655-a10d48d7ef03 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Tergazyme | 
| Version Model Number | .5 x 500 | 
| Catalog Number | 1305 | 
| Company DUNS | 001478726 | 
| Company Name | ALCONOX INC | 
| Device Count | 1 | 
| DM Exempt | false | 
| 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 | false | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00660483130597 [Primary] | 
| 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 | 2020-10-12 | 
| Device Publish Date | 2020-10-02 | 
| 00660483135011 | Cleaner for ultrasonic cleaning of medical devices | 
| 00660483132515 | Cleaner for ultrasonic cleaning of medical devices | 
| 00660483130597 | Cleaner for ultrasonic cleaning of medical devices | 
| 00660483130511 | Cleaner for ultrasonic cleaning of medical devices | 
| 00660483130498 | Cleaner for ultrasonic cleaning of medical devices | 
| 00660483130412 | Cleaner for ultrasonic cleaning of medical devices | 
| 00660483130313 | Cleaner for ultrasonic cleaning of medical devices | 
| 00660483130115 | Cleaner for ultrasonic cleaning of medical devices | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  TERGAZYME  87338739  5483686 Live/Registered | Alconox, Inc. 2017-02-16 | 
|  TERGAZYME  76624929  3048209 Dead/Cancelled | ALCONOX, INC. 2004-12-17 |