| Primary Device ID | 10817169023040 |
| NIH Device Record Key | d16b0a81-4c93-4cb0-9d0f-0f896fa2f834 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bioviva by 3D Dental |
| Version Model Number | SCG1637 |
| Company DUNS | 080194935 |
| Company Name | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817169023043 [Primary] |
| GS1 | 10817169023040 [Package] Contains: 00817169023043 Package: [12 Units] In Commercial Distribution |
| GAL | Suture, Absorbable, Natural |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-23 |
| Device Publish Date | 2021-06-15 |
| 10817169023040 | BIOVIVA SUTURE CHROMIC GUT C-6 4/0 18" |
| 00810126505620 | BIOVIVA SUTURE CHROMIC GUT TAPER POINT 4-0 RB1 1/2 27" 18MM |
| 00810126505521 | BIOVIVA SUTURE CHROMIC GUT TAPER POINT 3-0 SH 1/2 27" 26MM |
| 10810126503418 | BIOVIVA SUTURE CHROMIC GUT REVERSE CUTTING 5/0 P-3 3/8 18" 13MM |
| 00810126506580 | Bioviva Suture Chromic Gut 3/0 27",Taper Point,1/2, 18mm RB1 Needle Single |