| Primary Device ID | 00844868052142 |
| NIH Device Record Key | 9a182c4d-f990-4360-ab09-6a5a6ca092ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Patient ACT® Pointed Starter Drill |
| Version Model Number | SPACTPSD |
| Catalog Number | N/A |
| Company DUNS | 186127825 |
| Company Name | BIOMET 3I, LLC |
| 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 | 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 |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| dentalCS@zimvie.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844868052142 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-26 |
| Device Publish Date | 2025-12-18 |
| 00844868051824 - Single Patient ACT® Twist Drill | 2025-12-26 Single Patient ACT® Twist Drill, 2mmD x 15mmL |
| 00844868051831 - Single Patient ACT® Twist Drill, 2mmD x 10mmL | 2025-12-26 Single Patient ACT® Twist Drill, 2mmD x 10mmL |
| 00844868051848 - Single Patient ACT® Twist Drill | 2025-12-26 Single Patient ACT® Twist Drill, 2mmD x 20mmL |
| 00844868051855 - Single Patient ACT® Twist Drill | 2025-12-26 Single Patient ACT® Twist Drill, 2mmD x 6mmL |
| 00844868051862 - Single Patient ACT® Twist Drill | 2025-12-26 Single Patient ACT® Twist Drill, 2.75mmD x 10mmL |
| 00844868051879 - Single Patient ACT® Twist Drill | 2025-12-26 Single Patient ACT® Twist Drill, 2.75mmD x 15mmL |
| 00844868051886 - Single Patient ACT® Twist Drill | 2025-12-26 Single Patient ACT® Twist Drill, 2.75mmD x 20mmL |
| 00844868051893 - Single Patient ACT® Twist Drill | 2025-12-26 Single Patient ACT® Twist Drill, 3mmD x 10mmL |