| Primary Device ID | EDEL16052600 |
| NIH Device Record Key | 69025dd3-4388-467c-bf98-3d3ac8042c11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3Delta Guide XT |
| Version Model Number | 1605260 |
| Catalog Number | 1605260 |
| Company DUNS | 344805101 |
| Company Name | DeltaMed GmbH |
| 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 | true |
| 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 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDEL16052600 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-02 |
| Device Publish Date | 2025-11-24 |
| 04260635981570 - RS VIVO Guide | 2025-12-02 RS VIVO Guide 1000g |
| EDEL16052600 - 3Delta Guide XT | 2025-12-023Delta Guide XT 1000g |
| EDEL16052600 - 3Delta Guide XT | 2025-12-02 3Delta Guide XT 1000g |
| 04260635981587 - RS VIVO Tray | 2025-08-06 RS VIVO Tray 1000g |
| 04260635981594 - RS VIVO Try-In | 2025-08-06 RS VIVO Try-In 1000g |
| EDEL16211210 - 3Delta Try-In XT | 2025-08-06 3Delta Try-In XT 1000g |
| EDEL16216200 - 3Delta Tray Rose | 2025-08-06 3Delta Tray Rose 1000g |
| 04260635981600 - RS VIVO C&B Ultimate | 2025-07-03 RS VIVO C&B Ultimate A1 500g |
| 04260635981617 - RS VIVO C&B Ultimate | 2025-07-03 RS VIVO C&B Ultimate A2 500g |