Everest / MegaPlus

GUDID 08800118602200

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic
Primary Device ID08800118602200
NIH Device Record Key8f583b5c-7541-4048-a05b-01ac59657101
Commercial Distribution StatusIn Commercial Distribution
Brand NameEverest / MegaPlus
Version Model NumberD 1100 A0 18
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
GS108800118602200 [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 Date2022-02-21
Device Publish Date2022-02-11

On-Brand Devices [Everest / MegaPlus]

08800118601005W 800 A0 18
08800118602002D 1300 A3 10
08800118601999D 1300 A2 25
08800118601982D 1300 A2 22
08800118601975D 1300 A2 20
08800118601968D 1300 A2 18
08800118601951D 1300 A2 16
08800118601944D 1300 A2 14
08800118601937D 1300 A2 12
08800118601920D 1300 A2 10
08800118601913D 1300 A1 25
08800118601906D 1300 A1 22
08800118601890D 1300 A1 20
08800118601883D 1300 A1 18
08800118601876D 1300 A1 16
08800118601869D 1300 A1 14
08800118601852D 1300 A1 12
08800118601845D 1300 A1 10
08800118601838D 1300 A0 25
08800118601821D 1300 A0 22
08800118601814D 1300 A0 20
08800118601807D 1300 A0 18
08800118601791D 1300 A0 16
08800118601784D 1300 A0 14
08800118601777D 1300 A0 12
08800118601760D 1300 A0 10
088001186017535188 LT WH 98-25
088001186017465187 LT WH 98-22
088001186017395186 LT WH 98-20
088001186017225185 LT WH 98-18
088001186017155184 LT WH 98-16
088001186017085183 LT WH 98-14
088001186016925182 LT WH 98-12
088001186016855181 LT WH 98-10
088001186016785178 LT A2 98-25
088001186016615177 LT A2 98-22
088001186016545176 LT A2 98-20
088001186016475175 LT A2 98-18
088001186016305174 LT A2 98-16
088001186016235173 LT A2 98-14
088001186016165172 LT A2 98-12
088001186016095171 LT A2 98-10
088001186015935168 HT WH 98-25
088001186015865167 HT WH 98-22
088001186015795166 HT WH 98-20
088001186015625165 HT WH 98-18
088001186015555164 HT WH 98-16
088001186015485163 HT WH 98-14
088001186015315162 HT WH 98-12
088001186015245161 HT WH 98-10

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