| Primary Device ID | 08435389820345 | 
| NIH Device Record Key | 1805214f-98b4-4b01-aebd-24704abe9ad6 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | EXPANDED HEALING CAP MULTI-IM WIDE PLATFORM | 
| Version Model Number | TPMIPAEX | 
| Company DUNS | 461665312 | 
| Company Name | BIOTECHNOLOGY INSTITUTE SL | 
| 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 | 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 | 2156464067 | 
| janderson@bti-implant.us | |
| Phone | 2156464067 | 
| janderson@bti-implant.us | |
| Phone | 2156464067 | 
| janderson@bti-implant.us | |
| Phone | 2156464067 | 
| janderson@bti-implant.us | |
| Phone | 2156464067 | 
| janderson@bti-implant.us | |
| Phone | 2156464067 | 
| janderson@bti-implant.us | |
| Phone | 2156464067 | 
| janderson@bti-implant.us | |
| Phone | 2156464067 | 
| janderson@bti-implant.us | |
| Phone | 2156464067 | 
| janderson@bti-implant.us | |
| Phone | 2156464067 | 
| janderson@bti-implant.us | |
| Phone | 2156464067 | 
| janderson@bti-implant.us | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08435389820345 [Primary] | 
| DZE | Implant, Endosseous, Root-Form | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08435389820345]
Moist Heat or Steam Sterilization
[08435389820345]
Moist Heat or Steam Sterilization
[08435389820345]
Moist Heat or Steam Sterilization
[08435389820345]
Moist Heat or Steam Sterilization
[08435389820345]
Moist Heat or Steam Sterilization
[08435389820345]
Moist Heat or Steam Sterilization
[08435389820345]
Moist Heat or Steam Sterilization
[08435389820345]
Moist Heat or Steam Sterilization
[08435389820345]
Moist Heat or Steam Sterilization
[08435389820345]
Moist Heat or Steam Sterilization
[08435389820345]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-06-12 | 
| Device Publish Date | 2019-06-04 |