TRAUS SIP10

GUDID 08809260470729

20:1 , optic XIP10+FUS10+CRB26LX+MBP10SL

Saeshin Precision Co., Ltd.

Dental power tool system, line-powered
Primary Device ID08809260470729
NIH Device Record Key7a6318a7-6c07-404e-8d52-3b74833caacb
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRAUS SIP10
Version Model NumberTRAUS SIP10 #3
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809260470729 [Primary]

FDA Product Code

EKYHandpiece, Water-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809260470729]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-30
Device Publish Date2020-01-22

On-Brand Devices [TRAUS SIP10]

0880926047073620:1 , non-optic XIP10+FUS10+CRB26XX+MBP10SX
0880926047072920:1 , optic XIP10+FUS10+CRB26LX+MBP10SL
0880926047071232:1 , non-optic XIP10+FUS10+CRB27XX+MBP10SX
08809260470705XIP10+FUS10+CRB27LX+MBP10SL 32:1 , optic
08809260470163Control Box 272.0(W) x 203.0(D) x 67.4(H)

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