TRAUS Dental Handpiece

GUDID 08809260471559

'20:1, Optic

Saeshin Precision Co., Ltd.

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Primary Device ID08809260471559
NIH Device Record Keycff23c07-469b-4b25-a713-8641e4e470a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRAUS Dental Handpiece
Version Model NumberTRAUS CRB46LN
Company DUNS688019566
Company NameSaeshin Precision Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108809260471559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


[08809260471559]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-30
Device Publish Date2020-12-22

On-Brand Devices [TRAUS Dental Handpiece]

0880926047156620:1, Non-Optic
08809260471559'20:1, Optic

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