Primary Device ID | 00810027860163 |
NIH Device Record Key | e2bdb0a7-d47e-4531-9447-ee5d61a3badf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | One Stage TL |
Version Model Number | I3032070 |
Company DUNS | 026108395 |
Company Name | I3 IMPLANT LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810027860163 [Primary] |
NHA | Abutment, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810027860163]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-11-08 |
Device Publish Date | 2019-06-14 |
00810027860019 | I3022020 |
00810027860002 | I3022010 |
00810027860200 | I3032120 |
00810027860194 | I3032110 |
00810027860187 | I3032100 |
00810027860170 | I3032090 |
00810027860163 | I3032070 |
00810027860156 | I3032050 |
00810027860149 | I3032030 |
00810027860132 | I3032020 |
00810027860125 | I3032010 |
00810027860118 | I3023050 |
00810027860101 | I3023040 |
00810027860095 | I3023030 |
00810027860088 | I3023020 |
00810027860071 | I3023010 |
00810027860064 | I3022070 |
00810027860057 | I3022060 |
00810027860040 | I3022050 |
00810027860033 | I3022040 |
00810027860026 | I3022030 |