Razor / MegaPlus

GUDID 08800118609117

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic
Primary Device ID08800118609117
NIH Device Record Keye2e7cd9d-5922-45a0-b768-f227ec1472ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameRazor / MegaPlus
Version Model NumberW 1300 C3 25
Company DUNS694821663
Company NameU&C International 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 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
GS108800118609117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-22
Device Publish Date2022-02-14

On-Brand Devices [Razor / MegaPlus]

08800118600992W 800 A0 16
08800118600985W 800 A0 14
08800118600978W 800 A0 12
08800118600961W 800 A0 10
08800118600954W 1100 ML 25
08800118600947W 1100 ML 22
08800118600930W 1100 ML 20
08800118600923W 1100 ML 18
08800118600916W 1100 ML 16
08800118600909W 1100 ML 14
08800118600893W 1100 ML 12
08800118600879W 1100 A4 25
08800118600862W 1100 A4 22
08800118600855W 1100 A4 20
08800118600848W 1100 A4 18
08800118600831W 1100 A4 16
08800118600824W 1100 A4 14
08800118600817W 1100 A4 12
08800118600800W 1100 A4 10
08800118600794W 1100 A3 25
08800118600787W 1100 A3 22
08800118600770W 1100 A3 20
08800118600763W 1100 A3 18
08800118600756W 1100 A3 16
08800118600749W 1100 A3 14
08800118600732W 1100 A3 12
08800118600725W 1100 A3 10
08800118600718W 1100 A2 25
08800118600701W 1100 A2 22
08800118600695W 1100 A2 20
08800118600688W 1100 A2 18
08800118600671W 1100 A2 16
08800118600664W 1100 A2 14
08800118600657W 1100 A2 12
08800118600640W 1100 A2 10
08800118600633W 1100 A1 25
08800118600626W 1100 A1 22
08800118600619W 1100 A1 20
08800118600602W 1100 A1 18
08800118600596W 1100 A1 16
08800118600589W 1100 A1 14
08800118600572W 1100 A1 12
08800118600565W 1100 A1 10
08800118600558W 1100 A0 25
08800118600541W 1100 A0 22
08800118600534W 1100 A0 20
08800118600527W 1100 A0 18
08800118600510W 1100 A0 16
08800118600503W 1100 A0 14
08800118600497W 1100 A0 12

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