Primary Device ID | 10817169021596 |
NIH Device Record Key | c5120c54-5ea3-41e3-bcfc-5c1160995137 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 3D Dental- Bioviva |
Version Model Number | SPG592 |
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 | 00817169021599 [Primary] |
GS1 | 10817169021596 [Package] Contains: 00817169021599 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" |