Primary Device ID | 00810126505521 |
NIH Device Record Key | eb81840b-ecfc-4c60-b423-9dc91de6d12e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bioviva by 3D Dental |
Version Model Number | SCG122 |
Catalog Number | SCG122 |
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 | 00810126505521 [Primary] |
GS1 | 10810126505528 [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 |