| Primary Device ID | 19335006007431 |
| NIH Device Record Key | 02c5be82-cd24-4b6c-a722-c68531afb44b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endocept |
| Version Model Number | 1 |
| Company DUNS | 750968679 |
| Company Name | WHITELEY CORPORATION PTY LTD |
| 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 | 09335006007403 [Primary] |
| GS1 | 19335006007431 [Package] Contains: 09335006007403 Package: Carton [12 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 | 2025-06-20 |
| Device Publish Date | 2025-06-12 |
| 19335006007431 | Multi-function enzymatic detergent for manual and automated reprocessing of surgical instruments |
| 19335006007448 | Multi-function enzymatic detergent for manual and automated reprocessing of surgical instruments |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDOCEPT 98746815 not registered Live/Pending |
WHITELEY USA INC. 2024-09-12 |