MedtechSourcebook

RED STAR CONTRACT MANUFACTURING INC.

Contract manufacturer ยท Larwill, IN

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

2021Product codes first listed, by year (tallest: 5)2026
FDA registration
3009631939 (openFDA record; or search FDA's registration database)
FEI number
3009631939
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
Red Star Contract Manufacturing (FDA owner/operator no. 10046073)
Registered address
1560 N State Road 5, Larwill, IN 46764
Contract listings
12 device listings, 12 product codes, first listed May 14, 2021
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
FTDLamp, SurgicalClass IIGeneral and plastic surgeryContract manufacturingMay 14, 2021
FTYTape, Measuring, Rulers And CalipersClass IGeneral and plastic surgeryContract manufacturingSep 28, 2022
FZXGuide, Surgical, InstrumentClass IGeneral and plastic surgeryContract manufacturingSep 28, 2022
HTWBit, DrillClass IOrthopedicContract manufacturingMay 14, 2021
HTYPin, Fixation, SmoothClass IIOrthopedicContract manufacturingMay 14, 2021
HWBExtractorClass IOrthopedicContract manufacturingMay 14, 2021
HWCScrew, Fixation, BoneClass IIOrthopedicContract manufacturingMar 5, 2026
HWTTemplateClass IOrthopedicContract manufacturingSep 28, 2022
HXXScrewdriverClass IOrthopedicContract manufacturingSep 28, 2022
JDRStaple, Fixation, BoneClass IIOrthopedicContract manufacturingOct 31, 2023
JYQLoop, WireClass IEar, nose and throatContract manufacturingDec 17, 2025
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingMay 14, 2021