Millstone Medical Outsourcing LLC
Registration 3010097171FEI 3010097171Olive Branch, MS
Owner/operator: MILLSTONE MEDICAL OUTSOURCING LLC.
- Manufacture Medical Device for Another Party (Contract Manufacturer)
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 158
- Added, last 12 months
- 9
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 158
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| KWP | Appliance, Fixation, Spinal InterlaminalOrthopedic | Class 2 | 21 CFR 888.3050 | — |
| KWQ | Indus invue ACP System/ invue ACP System/ Indus ACP SystemAppliance, Fixation, Spinal Intervertebral Body | Class 2 | 21 CFR 888.3060 | — |
| KWQ | Appliance, Fixation, Spinal Intervertebral BodyOrthopedic | Class 2 | 21 CFR 888.3060 | — |
| HRX | ArthroscopeOrthopedic | Class 2 | 21 CFR 888.1100 | — |
| NPL | Barrier, Animal Source, IntraoralDental | Class 2 | 21 CFR 872.3930 | — |
| LOD | Bone CementOrthopedic | Class 2 | 21 CFR 888.3027 | — |
| MBB | Bone Cement, AntibioticOrthopedic | Class 2 | 21 CFR 888.3027 | — |
| NUN | RegenerOssBone Grafting Material, Human Source | Class 2 | 21 CFR 872.3930 | — |
| JDQ | Cerclage, FixationOrthopedic | Class 2 | 21 CFR 888.3010 | — |
| DBI | COMPLEMENT C4, ANTIGEN, ANTISERUM, CONTROLComplement C4, Antigen, Antiserum, Control | Class 2 | 21 CFR 866.5240 | — |
| NQB | Conformer, Ophthalmic, Biological TissueOphthalmic | Class 2 | 21 CFR 886.3130 | — |
| FLL | Continuous Measurement ThermometerGeneral HospitalAdded Nov 17, 2025 | Class 2 | 21 CFR 880.2910 | — |
and 146 more on your full dossier
What changed
- Nov 17, 2025Listing added: FLL — Continuous Measurement Thermometer
- Nov 17, 2025Listing added: DPS — Electrocardiograph
- Nov 17, 2025Listing added: BZQ — Monitor, Breathing Frequency
- Nov 17, 2025Listing added: MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Nov 19, 2025Listing added: IRT — Pad, Heating, Powered
- Nov 17, 2025Listing added: DSB — Plethysmograph, Impedance
- Nov 17, 2025Listing added: DQD — Stethoscope, Electronic
- Nov 17, 2025Listing added: DXH — Transmitters And Receivers, Electrocardiograph, Telephone
- Nov 19, 2025Listing added: IME — Pack, Hot Or Cold, Reusable