SPI RETAIN

GUDID 07640156473711

Thommen Medical AG

Dental implant suprastructure, permanent, preformed
Primary Device ID07640156473711
NIH Device Record Keye2d102fa-7f3f-407a-96fb-4c3ef94dad56
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPI RETAIN
Version Model Number4.03.428
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
GS107640156473711 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640156473711]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-09-24

On-Brand Devices [SPI RETAIN]

076401564739644.03.040
076401564739574.03.041
076401564739404.03.042
076401564739334.03.043
076401564739264.03.048
076401564739194.03.049
076401564739024.03.070
076401564737974.03.380
076401564737804.03.381
076401564737734.03.382
076401564737664.03.388
076401564737594.03.420
076401564737424.03.421
076401564737354.03.422
076401564737284.03.423
076401564737114.03.428
076401564737044.03.500
076401564736984.03.502
076401564736814.03.506
076401564736744.03.507
076401564718304.03.501

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