| Primary Device ID | D1500SPI0838 |
| NIH Device Record Key | a4980e6f-1767-41ab-8a64-78f27dffa11c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GDT MOR Spiral Implant 3.75 x 8mm |
| Version Model Number | SPI0838 |
| Company DUNS | 532376847 |
| Company Name | GLOBAL DENTAL TRANSFER LTD |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D1500SPI0838 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-26 |
| Device Publish Date | 2024-06-18 |
| D15000LIRP05 - GDT Click Attachment Assortment | 2024-07-02 |
| D15000LIRP10 - GDT Click Attachment 1mm | 2024-07-02 |
| D15000LIRP20 - GDT Click Attachment 2mm | 2024-07-02 |
| D15000LIRP30 - GDT Click Attachment 3mm | 2024-07-02 |
| D15000LIRP40 - GDT Click Attachment 4mm | 2024-07-02 |
| D15000LIRP50 - GDT Click Attachment 5mm | 2024-07-02 |
| D15000LIRP60 - GDT Click Attachment 6mm | 2024-07-02 |
| D1500MUSRP10 - GDT Straight Multi-Unit 1.6mm - 1mm | 2024-07-02 |