MedtechSourcebook

Insight Surgery Nebraska

Contract manufacturer · Omaha, NE

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3038011206 (openFDA record; or search FDA's registration database)
FEI number
3038011206
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
3D LifePrints UK (FDA owner/operator no. 10085716)
Registered address
3D Imaging and Advanced Visualization Unit, 8404 Indian Hills Drive, Omaha, NE 68114
Contract listings
2 device listings, 3 product codes, first listed Feb 8, 2023
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
DZJDriver, Wire, And Bone Drill, ManualClass IIDentalContract manufacturingFeb 8, 2023
LLZSystem, Image Processing, RadiologicalClass IIRadiologyContract manufacturingFeb 8, 2023
PBFOrthopaedic Surgical Planning And Instrument GuidesClass IIOrthopedicContract manufacturingMay 17, 2023