| Primary Device ID | 10810138822682 |
| NIH Device Record Key | 9b619c0e-7f30-4b84-9874-0f0b20c190e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endo Direct 17% EDTA |
| Version Model Number | EDEDTA480ML |
| Company DUNS | 125216703 |
| Company Name | Endo Direct LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10810138822682 [Primary] |
| KJJ | Cleanser, Root Canal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-24 |
| Device Publish Date | 2023-07-15 |
| 10810138823276 - RC Mix | 2025-03-11 |
| 10810138823269 - ProShape Orifice Barrier | 2025-01-21 |
| 10810138823245 - ProShape Path Size 13 21mm | 2024-11-22 |
| 10810138823252 - ProShape Path Size 13 25mm | 2024-11-22 |
| 10810138823238 - EndoCeramic Root Repair Material | 2024-10-29 |
| 10810138822736 - ProShape Gutta Percha F1 | 2024-08-12 |
| 10810138822743 - ProShape Gutta Percha F2 | 2024-08-12 |
| 10810138822750 - ProShape Gutta Percha F3 | 2024-08-12 |