| Primary Device ID | 10841307117780 |
| NIH Device Record Key | 10fd03e4-ffad-4ba2-8aec-1f52ad15a183 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | simplyFixed Legacy™ Angled |
| Version Model Number | 8035-64-15SK |
| Catalog Number | 8035-64-15SK |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307117780 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307117780]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2015-10-02 |
| 10841307117865 | 8045-64-30SK |
| 10841307117858 | 8045-63-30SK |
| 10841307117841 | 8045-64-15SK |
| 10841307117834 | 8045-62-15SK |
| 10841307117803 | 8035-64-30SK |
| 10841307117797 | 8035-63-30SK |
| 10841307117780 | 8035-64-15SK |
| 10841307117773 | 8035-62-15SK |
| 10841307117742 | 8530-63-30SK |
| 10841307117735 | 8530-63-15SK |
| 10841307117728 | 8530-62-15SK |