Ratchet Wrench

GUDID 08806169139610

Dental Implant Instrument / Ratchet Wrench

DENTIS CO. ,LTD

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Primary Device ID08806169139610
NIH Device Record Key40ad5603-65b5-4c50-a106-3c6edbaa1057
Commercial Distribution StatusIn Commercial Distribution
Brand NameRatchet Wrench
Version Model NumberDRW
Company DUNS694721181
Company NameDENTIS CO. ,LTD
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806169139610 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


[08806169139610]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

Devices Manufactured by DENTIS CO. ,LTD

08800053091305 - Luvis Chair (LC700C-chair only)2024-04-03 A Dental Chair to provide patient supporting and positioning during dental treatment.
08806169138965 - s-Clean Ratchet Driver2024-04-02 s-Clean Ratchet Driver (DRMDSEL)
08800053082808 - MESHEET0752024-03-13 MESHEET075
08800053082815 - MESHEET075-R2024-03-13
08800053042093 - DENOPS2024-01-31 DC : 3.7 V, 550mh(Battery)
08800053045032 - LUVIS-C600 Series2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA
08800053045049 - LUVIS-C600 Series2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA
08800053045056 - LUVIS-C600 Series2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA

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