Primary Device ID | D1351480 |
NIH Device Record Key | 210643e2-cc36-4747-a8d5-811dd0224a9e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DOME Coronado Dental Delivery Unit |
Version Model Number | 148 |
Catalog Number | 148 |
Company DUNS | 053883807 |
Company Name | Dome, 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 | false |
Serial Number | true |
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 |
Phone | 818-344-3404 |
info@domeortho.com | |
Phone | 818-344-3404 |
info@domeortho.com | |
Phone | 818-344-3404 |
info@domeortho.com |
Height | 30 Inch |
Height | 30 Inch |
Height | 30 Inch |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D1351480 [Primary] |
NRD | Unit, Operative Dental, Accessories |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D1351480]
Liquid Chemical
[D1351480]
Liquid Chemical
[D1351480]
Liquid Chemical
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-01-23 |
Device Publish Date | 2025-01-15 |
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