Primary Device ID | 08806145440129 |
NIH Device Record Key | 1edd85ba-95f3-4f79-9e99-8ef88bd6407a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Orthodontic Driver |
Version Model Number | LHD-B+DT-L |
Company DUNS | 688355973 |
Company Name | DENTOS 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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 | 08806145440129 [Primary] |
ECT | Driver, Band, Orthodontic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
[08806145440129]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-12 |
Device Publish Date | 2025-05-02 |
08806145435040 | LHD-OB-L |
08806145435033 | LHD-OB-S |
08806145435026 | LHD-B-TG |
08806145484086 | NLHD-S |
08806145440174 | NLHD-S+ST-S |
08806145440167 | NLHD-S+ST-L |
08806145440150 | NLHD+ST-S |
08806145440143 | NLHD+ST-L |
08806145440136 | LHD-B+DT-S |
08806145440129 | LHD-B+DT-L |