| Primary Device ID | 00841307129557 |
| NIH Device Record Key | 4bf78b75-2704-4af3-bc02-7ffd66249f1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fixation Screw |
| Version Model Number | 1000-15 |
| Catalog Number | 1000-15 |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 2 |
| DM Exempt | false |
| 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 | 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841307129557 [Unit of Use] |
| GS1 | 10841307129554 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
[00841307129557]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-20 |
| Device Publish Date | 2024-03-12 |
| 00841307126228 | 1000-42 |
| 00841307126211 | 1000-41 |
| 00841307126129 | 1000-28 |
| 00841307126082 | 1000-23 |
| 00841307126075 | 1000-22 |
| 00841307126037 | 1000-19 |
| 00841307129502 | 1000-06 |
| 00841307129557 | 1000-15 |