Contract manufacturerContract sterilizerMAINSTREAM MEDICAL DEVICES (Austin, TX)TexasDentalGeneral and plastic surgeryGastroenterology and urologyNeurologyOrthopedicCardiovascularGeneral hospitalClass IClass II
MAINSTREAM MEDICAL DEVICES
Contract manufacturer and sterilizer ยท Austin, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3016112537 (openFDA record; or search FDA's registration database)
- FEI number
- 3016112537
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Manufacturer; Contract manufacturer; Contract sterilizer
- Owner or operator
- Mainstream Medical Devices (FDA owner/operator no. 10061802)
- Registered address
- 3913 Todd Lane, Suites 304; 112, Austin, TX 78744
- Contract listings
- 35 device listings, 29 product codes, first listed May 14, 2020
- 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 code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Class I | Dental | Contract manufacturing | May 17, 2021 |
| FZO | Chisel, Surgical, Manual | Class I | General and plastic surgery | Contract manufacturing | May 14, 2020 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Jan 7, 2026 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Jan 13, 2022 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Jul 12, 2023 |
| HAE | Rongeur, Manual | Class II | Neurology | Contract manufacturing | Jun 19, 2026 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 12, 2022 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Jun 19, 2026 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Nov 29, 2023 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Nov 29, 2023 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Nov 29, 2023 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 12, 2022 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Jul 12, 2023 |
| HXL | Mallet | Class I | General and plastic surgery | Contract manufacturing | Apr 1, 2025 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Nov 29, 2023 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Aug 6, 2024 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | May 15, 2026 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Jan 13, 2022 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Dec 23, 2020 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract sterilization | Dec 23, 2020 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Nov 25, 2024 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | Class I | Orthopedic | Contract manufacturing | Nov 22, 2024 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Sep 26, 2022 |
| OFC | Catheter Introducer Kit | Class II | Cardiovascular | Contract manufacturing | Nov 5, 2023 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | Sep 26, 2022 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Nov 9, 2023 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | May 15, 2026 |
| PEK | Spinous Process Plate | Class II | Orthopedic | Contract manufacturing | Nov 17, 2023 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Class II | Orthopedic | Contract manufacturing | Nov 9, 2023 |
| PXB | Percutaneous Introducer Kit | Class II | General hospital | Contract manufacturing | Nov 5, 2023 |