MF Controller

GUDID 08800016162004

Cowellmedi Co.,Ltd

Dental osteotome
Primary Device ID08800016162004
NIH Device Record Key770411be-f7d6-4d7e-bca3-ed022ae2547c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMF Controller
Version Model NumberKLSMFC
Company DUNS688753763
Company NameCowellmedi 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
GS108800016162004 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


[08800016162004]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-05
Device Publish Date2026-01-28

Devices Manufactured by Cowellmedi Co.,Ltd

08800016163070 - Dental Instrument2026-02-06
08800016176841 - Dental Instrument2026-02-06
08800016176858 - Dental Instrument2026-02-06
08800016176865 - Dental Instrument2026-02-06
08800016101362 - Dental Instrument2026-02-05
08800016114256 - Dental Implants Accesseories-Single Use2026-02-05
08800016114447 - Dental Instrument2026-02-05
08800016114454 - Dental Instrument2026-02-05

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