| Primary Device ID | 08435452017399 | 
| NIH Device Record Key | 0d331ff7-71be-4f0d-b837-d03ce3a5fe40 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AVINENT | 
| Version Model Number | 4814 | 
| Company DUNS | 477451012 | 
| Company Name | AVINENT IMPLANT SYSTEM SLU | 
| Device Count | 1 | 
| DM Exempt | true | 
| 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 | 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 | 08435452017399 [Primary] | 
| NDP | Accessories, implant, dental, endosseous | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08435452017399]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-09-23 | 
| Device Publish Date | 2019-09-13 | 
| 08435452018488 | Scan Analog Prima PlusTM Ø5,0 CORE3D | 
| 08435452018471 | Scan Analog Prima PlusTM Ø4,1 CORE3D | 
| 08435452018464 | Scan Analog Prima PlusTM Ø3,5 CORE3D | 
| 08435452018457 | Scan Analog Genesis Ø3,5 CORE3D | 
| 08435452018440 | Scan Analog Prima PlusTM Ø6,0 CORE3D | 
| 08435452018358 | Scan Analog TILOBEMAXXTM Ø8,0 CORE3D | 
| 08435452018341 | Scan Analog TILOBEMAXXTM Ø7,0 CORE3D | 
| 08435452018334 | Scan Analog Genesis Ø6,5 CORE3D | 
| 08435452018327 | Scan Analog Genesis Ø5,5 CORE3D | 
| 08435452018310 | Scan Analog Genesis Ø4,5 CORE3D | 
| 08435452018303 | Scan Analog Genesis Ø3,8 CORE3D | 
| 08435452018297 | Scan Analog PrimaConnex® Ø5,0 CORE3D | 
| 08435452018280 | Scan Analog PrimaConnex® Ø4,1 CORE3D | 
| 08435452018273 | Scan Analog PrimaConnex® Ø3,5 CORE3D | 
| 08435452017405 | Scan Abutment Prima PlusTM Ø6,0 CORE3D | 
| 08435452017399 | Scan Abutment Prima PlusTM Ø5,0 CORE3D | 
| 08435452017382 | Scan Abutment Prima PlusTM Ø4,1 CORE3D | 
| 08435452017375 | Scan Abutment Prima PlusTM Ø3,5 CORE3D | 
| 08435452017368 | Scan Abutment TILOBEMAXXTM Ø8,0 CORE3D | 
| 08435452017351 | Scan Abutment TILOBEMAXXTM Ø7,0 CORE3D | 
| 08435452017344 | Scan Abutment Genesis Ø6,5 CORE3D | 
| 08435452017337 | Scan Abutment Genesis Ø5,5 CORE3D | 
| 08435452017320 | Scan Abutment Genesis Ø4,5 CORE3D | 
| 08435452017313 | Scan Abutment Genesis Ø3,8 CORE3D | 
| 08435452017306 | Scan Abutment Genesis Ø3,5 CORE3D | 
| 08435452017290 | Scan Abutment PrimaConnex® Ø5,0 CORE3D | 
| 08435452017283 | Scan Abutment PrimaConnex® Ø4,1 CORE3D | 
| 08435452017276 | Scan Abutment PrimaConnex® Ø3,5 CORE3D | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  AVINENT  88424146  not registered Live/Pending | Avinent Implant System, S.L. 2019-05-10 | 
|  AVINENT  86246511  not registered Live/Pending | Avinent Canada Ltd. 2014-04-08 |