TN-Brush TN-1.0

GUDID 08809552960600

DENTAL SCALER, ROTARY

GENOSS CO., Ltd.

Denture cleaning brush
Primary Device ID08809552960600
NIH Device Record Keyfd86b412-bda3-4797-b7b3-689ac44fccbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameTN-Brush
Version Model NumberTN-1.0
Catalog NumberTN-1.0
Company DUNS690083006
Company NameGENOSS CO., Ltd.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108809552960600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELBSCALER, ROTARY

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


[08809552960600]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-07-07
Device Publish Date2018-07-10

On-Brand Devices [TN-Brush]

08809552960600DENTAL SCALER, ROTARY
08809552960594DENTAL SCALER, ROTARY

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