| Primary Device ID | 00816273020177 |
| NIH Device Record Key | e1a9d77c-2f8a-46ff-b97b-b0b6357622a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | osseolink Implant |
| Version Model Number | 01914 |
| Company DUNS | 080083007 |
| Company Name | OSSEOLINK USA LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 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(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com | |
| Phone | +1(877)677-3688 |
| info@osseolink.com |
| Height | 4 Millimeter |
| Height | 4 Millimeter |
| Height | 4 Millimeter |
| Height | 4 Millimeter |
| Height | 4 Millimeter |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Device Size Text, specify | 0 |
| Height | 4 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816273020177 [Primary] |
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
[00816273020177]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-18 |
| 00816273020757 | Surgical Tray (no instruments) |
| 00816273020740 | Surgical Tray with Instrument set |
| 00816273020733 | Parallel Pin |
| 00816273020726 | Implant Placement Guide |
| 00816273020719 | Double Ended Depth Gauge |
| 00816273020702 | Driver Extension |
| 00816273020696 | Universal Implant Driver |
| 00816273020689 | Variable Torque Wrench |
| 00816273020672 | Driver Adapter |
| 00816273020665 | Hex Driver 0.05" (1.25 mm) |
| 00816273020658 | Tap Drill ø 5.0 mm |
| 00816273020641 | Tap Drill ø 4.0 mm |
| 00816273020634 | Tap Drill ø 3.5 mm |
| 00816273020627 | Countersink Drill ø 5.0 mm |
| 00816273020610 | Countersink Drill ø 4.5 mm |
| 00816273020603 | Countersink Drill ø 3.5 mm |
| 00816273020597 | Step Drill ø 5.0 mm |
| 00816273020580 | Step Drill ø 4.0 mm |
| 00816273020573 | Step Drill ø 3.5 mm |
| 00816273020566 | Drill- ø 2.8 mm-Short |
| 00816273020559 | Drill- ø 2.2 mm-Short |
| 00816273020542 | Drill-ø 4.9 mm-Long |
| 00816273020535 | Drill-ø 4.9 mm-Short |
| 00816273020528 | Drill-ø 4.3 mm-Long |
| 00816273020511 | Drill-ø 4.3 mm-Short |
| 00816273020504 | Drill-ø 3.9 mm-Long |
| 00816273020498 | Drill-ø 3.9 mm-Short |
| 00816273020481 | Drill-ø 3.3 mm-Long |
| 00816273020474 | Drill-ø 3.3 mm-Short |
| 00816273020467 | Drill- ø 2.5 mm-Long |
| 00816273020450 | Drill- ø 2.5 mm-Short |
| 00816273020443 | Drill- ø 2.0 mm-Long |
| 00816273020436 | Drill- ø 2.0 mm-Short |
| 00816273020429 | Lindemann Surgical Bur |
| 00816273020412 | Round Bur |
| 00816273020405 | Healing Abutments ø 6.0 mm,5.0 mm (H) |
| 00816273020399 | Healing Abutments ø 6.0 mm,3.0 mm (H) |
| 00816273020382 | Healing Abutments ø 5.0 mm,5.0 mm (H) |
| 00816273020375 | Healing Abutments ø 5.0 mm,3.0 mm (H) |
| 00816273020368 | Healing Abutments ø 4.0 mm,5.0 mm (H) |
| 00816273020351 | Healing Abutments ø 4.0 mm,3.0 mm (H) |
| 00816273020344 | Angled Abutment ø 5.5 |
| 00816273020337 | Angled Abutment ø 4.5 |
| 00816273020320 | Combination Abutment |
| 00816273020313 | Non anatomic Abutment-Titanium ø 5.5 mm,4.0 mm (H) |
| 00816273020306 | Non anatomic Abutment-Titanium ø 5.5 mm,0.5 mm (H) |
| 00816273020290 | Non anatomic Abutment-Titanium ø 5.5 mm,2.0 mm (H) |
| 00816273020283 | Non anatomic Abutment-Titanium ø 4.5 mm,4.0 mm (H) |
| 00816273020276 | Non anatomic Abutment-Titanium ø 4.5 mm, 0.5 mm (H) |
| 00816273020269 | Non anatomic Abutment-Titanium ø 4.5 mm,2.0 mm (H) |