i-Clean Shoulder Analog Pin

GUDID 08800053023023

Dental Implant Instrument / i-Clean Shoulder Analog Pin

DENTIS CO. ,LTD

Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog
Primary Device ID08800053023023
NIH Device Record Key0f640f83-cd26-4187-b649-ae585f1590cf
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Shoulder Analog Pin
Version Model NumberDISAPR
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 Usetrue
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
GS108800053023023 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

Moist Heat or Steam Sterilization


[08800053023023]

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

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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
08800053045063 - LUVIS-C600 Series2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA
08800053045070 - LUVIS-C700 Series2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA

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