DOME Coronado Dental Delivery Unit 148

GUDID D1351480

Dental delivery system instrument unit, pneumatic

Dome, Inc.

Dental delivery system instrument unit, pneumatic
Primary Device IDD1351480
NIH Device Record Key210643e2-cc36-4747-a8d5-811dd0224a9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDOME Coronado Dental Delivery Unit
Version Model Number148
Catalog Number148
Company DUNS053883807
Company NameDome, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com
Phone818-344-3404
Emailinfo@domeortho.com

Device Dimensions

Height30 Inch
Height30 Inch
Height30 Inch
Height30 Inch
Height30 Inch
Height30 Inch
Height30 Inch
Height30 Inch
Height30 Inch
Height30 Inch
Height30 Inch
Height30 Inch
Height30 Inch
Height30 Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD1351480 [Primary]

FDA Product Code

NRDUnit, Operative Dental, Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

[D1351480]

Liquid Chemical

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-23
Device Publish Date2025-01-15

Devices Manufactured by Dome, Inc.

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D1351480 - DOME Coronado Dental Delivery Unit2025-01-23 Dental delivery system instrument unit, pneumatic
D1355370 - DOME Innovation Chair2025-01-22 Dental chair, electric
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