Zubler

GUDID 08800118626602

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic
Primary Device ID08800118626602
NIH Device Record Keyd313ed10-ba9f-43cb-92ac-4ec1b5072996
Commercial Distribution StatusIn Commercial Distribution
Brand NameZubler
Version Model NumberW 1100 AA2 20
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
GS108800118626602 [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 Date2023-03-13
Device Publish Date2023-03-03

On-Brand Devices [Zubler]

08800118626664W 1100 ABL3 30
08800118626657W 1100 ABL3 25
08800118626640W 1100 AA2 30
08800118626633W 1100 AA2 28
08800118626626W 1100 AA2 25
08800118626619W 1100 AA2 22
08800118626602W 1100 AA2 20
08800118626596W 1100 AA2 18
08800118626589W 1100 AA2 16
08800118626572W 1100 AA2 14
08800118626565W 1100 AA2 12
08800118626558W 1100 AA2 10

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