| Primary Device ID | 00810126505620 | 
| NIH Device Record Key | 7dcea648-7888-46b7-9a3f-d87a5a8248b8 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Bioviva by 3D Dental | 
| Version Model Number | SCG203 | 
| Catalog Number | SCG203 | 
| Company DUNS | 080194935 | 
| Company Name | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | 
| Device Count | 1 | 
| DM Exempt | false | 
| 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 | true | 
| 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 | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00810126505620 [Primary] | 
| GS1 | 10810126505627 [Package] 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 | 2023-12-12 | 
| Device Publish Date | 2023-12-04 | 
| 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 |