SPI TEMPORARY

GUDID 07640156473803

Thommen Medical AG

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID07640156473803
NIH Device Record Key55597992-1c5b-4e96-a31f-f70f0dd1862f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPI TEMPORARY
Version Model Number4.03.089
Company DUNS481614829
Company NameThommen Medical AG
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107640156473803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640156473803]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-07
Device Publish Date2015-09-24

On-Brand Devices [SPI TEMPORARY]

076401564758212.03.740
076401564758142.03.741
076401564758072.03.742
076401564757912.03.743
076401564757842.03.744
076401564757772.03.745
076401564757602.03.746
076401564757532.03.747
076401564757462.03.748
076401564757392.03.749
076401564741453.03.802
076401564738964.03.080
076401564738894.03.081
076401564738724.03.082
076401564738654.03.083
076401564738584.03.084
076401564738414.03.085
076401564738344.03.086
076401564738274.03.087
076401564738104.03.088
076401564738034.03.089

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