| Primary Device ID | 00348783004915 |
| NIH Device Record Key | 55d49ced-1009-49b7-b8bb-dd22a0d0660e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sycamore Wood Wedges |
| Version Model Number | 9061105 |
| Company DUNS | 014789663 |
| Company Name | PREMIER DENTAL PRODUCTS COMPANY |
| Device Count | 4 |
| 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 | true |
| Expiration Date | false |
| 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 |
|---|---|
| GS1 | 00348783004915 [Unit of Use] |
| GS1 | 00348783005073 [Primary] |
| JEP | Retainer, Matrix |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-14 |
| Device Publish Date | 2024-08-06 |
| 00348783005103 | WEDGE BOX OF 400 ASSORTED (13T, 13, 15, UT) |
| 00348783004922 | WEDGE BOX OF 400 ULTRA THINS |
| 00348783004939 | WEDGE BOX OF 400 MINI |
| 00348783004915 | WEDGE BOX OF 400 - 17 |
| 00348783004908 | WEDGE BOX OF 400 - 16 |
| 00348783004892 | WEDGE BOX OF 400 - 15 |
| 00348783004861 | WEDGE BOX OF 400 - 13XT |
| 00348783004878 | WEDGE BOX OF 400 - 13T |
| 00348783004885 | WEDGE BOX OF 400 - 13 |