| Primary Device ID | 00844868052173 |
| NIH Device Record Key | a4c02348-fc7a-47bb-b119-18d1f26bb7d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Patient Countersink Drill |
| Version Model Number | SPCD600 |
| 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 | 00844868052173 [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 |
| 00844868052173 | Single Patient Countersink Drill, 6mmD |
| 00844868052166 | Single Patient Countersink Drill, 5mmD |
| 00844868052159 | Single Patient Countersink Drill, 4 mmD |