I3 Surgical Instruments

GUDID 00810027862860

I3 IMPLANT LLC

Dental implant system
Primary Device ID00810027862860
NIH Device Record Keya2a123ca-86b5-4379-b6f3-612cc1f92ee7
Commercial Distribution StatusIn Commercial Distribution
Brand NameI3 Surgical Instruments
Version Model NumberI3DXT
Company DUNS026108395
Company NameI3 IMPLANT LLC
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810027862860 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810027862860]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-18
Device Publish Date2019-07-10

On-Brand Devices [I3 Surgical Instruments]

00810027863119I3MMRP
00810027863102I3MMNP
00810027863096I3SDB
00810027863089I3SCD
00810027863072I3DP199
00810027863065I3RTT
00810027863058I3RR
00810027863041I3PP16
00810027863034I3PP10
00810027863027I3HA15
00810027863010I3HA07
00810027863003I3TRP17
00810027862990I3TNP15
00810027862983I3PD15
00810027862976I3PD07
00810027862969I3HD15
00810027862952I3HD07
00810027862945I3IMM242
00810027862938I3PMM125
00810027862921I3D520
00810027862914I3D420
00810027862907I3D365
00810027862891I3D320
00810027862884I3D280
00810027862877I3DLCSET
00810027862860I3DXT
00810027862853I3MD19
00810027862846I3SK1
00810027863577I3SRP07
00810027863560I3SNP07

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