Primary Device ID | G079INL1160130 |
NIH Device Record Key | efcef862-6963-470f-af58-2aed7008d687 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Inlet Bone Fixation System |
Version Model Number | INL-116-013 |
Company DUNS | 037368183 |
Company Name | Intelivation, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | G079INL1160130 [Primary] |
FZX | Guide, Surgical, Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
[G079INL1160130]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-08 |
Device Publish Date | 2024-01-31 |
G079INL139NT0700 | Temporary Pin, Non-threaded |
G079INL139NT0500 | Temporary Pin, Non-threaded |
G079INL139NT0400 | Temporary Pin, Non-threaded |
G079INL139NT0290 | Temporary Pin, Non-threaded |
G079INL1390700 | Temporary Pin |
G079INL1390500 | Temporary Pin |
G079INL1390400 | Temporary Pin |
G079INL1390290 | Temporary Pin |
G079INL1160200 | K-WIRE, Single Trocar, Round End, 6'' DIAXXmm |
G079INL1160160 | K-WIRE, Single Trocar, Round End, 6'' DIAXXmm |
G079INL1160130 | K-WIRE, Single Trocar, Round End, 6'' DIAXXmm |
G079INL1160110 | K-WIRE, Single Trocar, Round End, 6'' DIAXXmm |
G079INL1160080 | K-WIRE, Single Trocar, Round End, 6'' DIAXXmm |