Primary Device ID | D82852000130 |
NIH Device Record Key | e3b9a54c-b363-46ae-9a23-9796bce2b8d2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Vivos DNA |
Version Model Number | 5200013 |
Company DUNS | 113352686 |
Company Name | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC |
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 | false |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D82852000130 [Primary] |
DZC | Wire, Orthodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-05-14 |
Device Publish Date | 2018-04-11 |
D82851001560 - Bioliner Plus | 2023-02-20 |
D82852000920 - Vivos mmRNA | 2021-11-29 |
D8281330003 - FUJI SC BAND PASTE PAK | 2018-07-06 |
D8281330121 - FUJI LC BAND AUTOMIX | 2018-07-06 |
D8281330171 - ULTRA BAND LOK CLEAR | 2018-07-06 |
D8281330205 - LIGHT BOND PASTE TIPS | 2018-07-06 |
D8281330206 - SKINNY NOSE LIGHT BOND PASTE TIPS | 2018-07-06 |
D82813302070 - LIGHT BOND SYRINGE | 2018-07-06 |