| Primary Device ID | 06947600310143 |
| NIH Device Record Key | 7653fa70-1abe-446b-af91-33f2d34b4bfb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Implant Regular |
| Version Model Number | 313030 |
| Company DUNS | 527603266 |
| Company Name | BIO CONCEPT CO.,LTD |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06947600310143 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-17 |
| Device Publish Date | 2020-07-09 |
| 06947600313908 | 316060 |
| 06947600313892 | 316050 |
| 06947600313885 | 316040 |
| 06947600313878 | 316030 |
| 06947600313861 | 316020 |
| 06947600313830 | 315060 |
| 06947600313823 | 315050 |
| 06947600313816 | 315040 |
| 06947600313809 | 315030 |
| 06947600313793 | 315020 |
| 06947600310242 | 314070 |
| 06947600310235 | 314060 |
| 06947600310228 | 314050 |
| 06947600310211 | 314040 |
| 06947600310204 | 314030 |
| 06947600310198 | 314020 |
| 06947600310174 | 313060 |
| 06947600310167 | 313050 |
| 06947600310150 | 313040 |
| 06947600310143 | 313030 |
| 06947600310136 | 313020 |
| 06947600310129 | 313010 |
| 06947600310112 | 312060 |
| 06947600310105 | 312050 |
| 06947600310099 | 312040 |
| 06947600310082 | 312030 |
| 06947600310075 | 312020 |
| 06947600310068 | 312010 |