Dental Implants Accesseories-Single Use

GUDID 08800016110159

Cowellmedi Co.,Ltd

Dental impression tray, single-use
Primary Device ID08800016110159
NIH Device Record Keyd4795c8a-b617-45ce-a13e-da2c245f1a8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDental Implants Accesseories-Single Use
Version Model Number2SSFT4535LH
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 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
GS108800016110159 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


[08800016110159]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-16
Device Publish Date2024-08-08

On-Brand Devices [Dental Implants Accesseories-Single Use]

08809471728794INW600
08809471728787INR500
08809471728770IHW600
08809471728763IHR500
08809471727353IIOR001
08809471727346IIOW001
088000161447582SSFT3835H
088000161447412SSFT4535H
088000161447342SSFT5535H
088000161447272SSFT3850H
088000161445432SSFT4550H
088000161445362SSFT5550H
088000161445292SSFT3835N
088000161445122SSFT4535N
088000161445052SSFT5535N
088000161444992SSFT3850N
088000161444822SSFT4550N
088000161444752SSFT5550N
088000161444512SSFSB3835N
088000161444442SSFSB4535N
088000161444372SSFSB5535N
088000161444202SSFT3835BLH
088000161444132SSFT4535BLH
088000161444062SSFT5535BLH
088000161443902SSFT3835BLN
088000161443832SSFT4535BLN
088000161443762SSFT5535BLN
08800016144352ISB406B
08800016144345ISB410B
08800016112603SSB4325N
08800016112290ADIC001C
08800016112047ADSB001
088000161119342SSB4325
08800016111873ISB406
088000161117432SIH554S
088000161117362SIH454S
088000161116442SIN654S
088000161116372SIH654S
088000161116062SIN554S
088000161115902SIN454S
08800016110449ISB410
088000161103192SSFT4535LN
088000161103022SSFT5535LH
088000161102962SSFT5535LN
088000161101592SSFT4535LH
088000161101422SSFT3835LN
088000161101352SSFT3835LH
088000161099482SSFI5535B
088000161099312SSFI4535B
088000161099242SSFI3835B

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