| Primary Device ID | 10841307124894 |
| NIH Device Record Key | 980ac0ab-01ce-4cd2-8abd-5cc0c5ad35ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DLC Cortical Bone Drill 4.2mmD implant |
| Version Model Number | CBD4.2C |
| Catalog Number | CBD4.2C |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307124894 [Primary] |
| DZI | Drill, Bone, Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
[10841307124894]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-18 |
| Device Publish Date | 2020-08-10 |
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| 10841307134855 - DIRECTarch™ Cylinder – 6.0mm | 2025-05-01 |
| 10841307135197 - DIRECTscan™ Adapter Kit - Empty | 2025-05-01 |
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