Universal Speed

GUDID 08800118631606

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic
Primary Device ID08800118631606
NIH Device Record Key9ba921b1-9740-414a-ae0b-17fd5e00a86a
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Speed
Version Model NumberW ML UVS D4 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
GS108800118631606 [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 [Universal Speed]

08800118631897W ML UVS BL3 30
08800118631880W ML UVS BL3 28
08800118631873W ML UVS BL3 25
08800118631866W ML UVS BL3 22
08800118631859W ML UVS BL3 20
08800118631842W ML UVS BL3 18
08800118631835W ML UVS BL3 16
08800118631828W ML UVS BL3 14
08800118631811W ML UVS BL3 12
08800118631804W ML UVS BL2 30
08800118631798W ML UVS BL2 28
08800118631781W ML UVS BL2 25
08800118631774W ML UVS BL2 22
08800118631767W ML UVS BL2 20
08800118631750W ML UVS BL2 18
08800118631743W ML UVS BL2 16
08800118631736W ML UVS BL2 14
08800118631729W ML UVS BL2 12
08800118631712W ML UVS BL1 30
08800118631705W ML UVS BL1 28
08800118631699W ML UVS BL1 25
08800118631682W ML UVS BL1 22
08800118631675W ML UVS BL1 20
08800118631668W ML UVS BL1 18
08800118631651W ML UVS BL1 16
08800118631644W ML UVS BL1 14
08800118631637W ML UVS BL1 12
08800118631620W ML UVS D4 30
08800118631613W ML UVS D4 28
08800118631606W ML UVS D4 25
08800118631590W ML UVS D4 22
08800118631583W ML UVS D4 20
08800118631576W ML UVS D4 18
08800118631569W ML UVS D4 16
08800118631552W ML UVS D4 14
08800118631545W ML UVS D4 12
08800118631538W ML UVS D3 30
08800118631521W ML UVS D3 28
08800118631514W ML UVS D3 25
08800118631507W ML UVS D3 22
08800118631491W ML UVS D3 20
08800118631484W ML UVS D3 18
08800118631477W ML UVS D3 16
08800118631460W ML UVS D3 14
08800118631453W ML UVS D3 12
08800118631446W ML UVS D2 30
08800118631439W ML UVS D2 28
08800118631422W ML UVS D2 25
08800118631415W ML UVS D2 22
08800118631408W ML UVS D2 20

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