| Primary Device ID | 00817169021537 |
| NIH Device Record Key | 6959d969-6d68-41dc-914a-0eb3acc9aed6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3D Dental- Bioviva |
| Version Model Number | SCG635 |
| 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 | 00817169021537 [Primary] |
| GS1 | 10817169021534 [Package] Package: [12 Units] In Commercial Distribution |
| GAL | Suture, Absorbable, Natural |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-12-04 |
| 00817169021964 | Bioviva Soluble Dental Hemostatic Gauze |
| 10817169021671 | BIOVIVA SUTURE PLAIN GUT C-6 4/0 18" |
| 10817169021657 | BIOVIVA SUTURE PLAIN GUT C-7 3/0 27" |
| 10817169021633 | BIOVIVA SUTURE PLAIN GUT C-3 5/0 18" |
| 10817169021619 | BIOVIVA SUTURE PLAIN GUT C-31 3/0 18" |
| 10817169021596 | BIOVIVA SUTURE PLAIN GUT C-6 3/0 18" |
| 10817169021572 | BIOVIVA SUTURE PLAIN GUT C-6 4/0 27" |
| 10817169021558 | BIOVIVA SUTURE CHROMIC GUT C-6 3/0 27" |
| 00817169021537 | BIOVIVA SUTURE CHROMIC GUT C-6 4/0 27" |
| 00817169021513 | BIOVIVA SUTURE CHROMIC GUT C-6 3/0 18" |
| 00817169021506 | BIOVIVA SUTURE CHROMIC GUT C-6 4/0 18" 12/BX |
| 00817169021490 | BIOVIVA SUTURE CHROMIC GUT C-6 4/0 18" |