| Primary Device ID | D248938520 |
| NIH Device Record Key | 4b1a06ed-f50f-4dae-884d-b0e6aac4c328 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Uni-Wedge Regular ( Orange) |
| Version Model Number | 93852 |
| Company DUNS | 009277971 |
| Company Name | HAGER WORLDWIDE, INC. |
| Device Count | 250 |
| 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 | false |
| 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 |
|---|---|
| HIBCC | D248938520 [Unit of Use] |
| HIBCC | D248938521 [Primary] |
| EIF | Accessories, Retractor, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-05 |
| Device Publish Date | 2026-01-28 |
| D248938520 - Uni-Wedge Regular ( Orange) | 2026-02-05Dental wedges |
| D248938520 - Uni-Wedge Regular ( Orange) | 2026-02-05 Dental wedges |
| D2486300620 - TS1 Tongue Vacuum Cleaner | 2024-08-28 Tongue scraper |
| D2483552470 - The Prepster (also known as LaminateButler) | 2024-07-23 Chairside organizer for dental restorative cases |
| D2483552520 - BurButler ( 5 Hole Orange Base w/Lid) | 2024-07-23 Dental bur holder |
| D2483552530 - BurButler ( 10 Hole White Base w/Lid) | 2024-07-23 Dental bur holder |
| D2483552540 - BurButler ( 10 Hole Pink Base w/Lid) | 2024-07-23 Dental bur holder |
| D2483552560 - BurButler ( 10 Hole Blue Base w/Lid) | 2024-07-23 Dental bur holder |
| D2483552600 - BurButler ( 25 Hole Pink Base w/Lid) | 2024-07-23 Dental bur holder |