High-speed Turbine Handpieces for Single Use

GUDID 06970278690422

Beijing Dongbo Dental Handpiece Co.,Ltd.

Dental power tool system handpiece, pneumatic
Primary Device ID06970278690422
NIH Device Record Key654beff5-aaaf-4b3b-904d-d6f0f8b53f0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHigh-speed Turbine Handpieces for Single Use
Version Model NumberTBY03-DZJQ
Company DUNS544504276
Company NameBeijing Dongbo Dental Handpiece 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970278690309 [Primary]
GS106970278690422 [Package]
Contains: 06970278690309
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-16
Device Publish Date2020-03-06

On-Brand Devices [High-speed Turbine Handpieces for Single Use]

06970278690125TBY03-BKJW
06970278690118TBY03-BZJW
06970278690101TBY03-BZJ
06970278690095TBY03-BKJ
06970278690088TBY03-BK
06970278690071TBY03-DKJW
06970278690064TBY03-DZJW
06970278690057TBY03-DZJ
06970278690040TBY03-DKJ
06970278690033TBY03-DK
06970278690026TBY04-DZJ
06970278690019TBY04-DKJ
06970278690484TBY03-XZJ
06970278690477TBY03-XKJ
06970278690460TBY03-XZJG
06970278690453TBY03-BZG
06970278690446TBY03-BZ
06970278690439TBY03-DKJQ
06970278690422TBY03-DZJQ
06970278690293TBY03-DKJQW
06970278690408TBY03-DZJQW
06970278690392TBY03-DZG
06970278690385TBY03-DZ
06970278690378TBY04-DZJG

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