Contract manufacturerFIRST ARTICLE INC (Souderton, PA)PennsylvaniaCardiovascularGastroenterology and urologyNeurologyOrthopedicClass IIUnclassified
FIRST ARTICLE INC
Contract manufacturer ยท Souderton, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010032903 (openFDA record; or search FDA's registration database)
- FEI number
- 3010032903
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- First Article MFG LLC (FDA owner/operator no. 10095684)
- Registered address
- 150 S Front St Suite B, Souderton, PA 18964
- Contract listings
- 86 device listings, 30 product codes, first listed Apr 14, 2026
- 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 |
|---|---|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | Class II | Cardiovascular | Contract manufacturing | Apr 14, 2026 |
| FIP | Subsystem, Water Purification | Class II | Gastroenterology and urology | Contract manufacturing | Apr 14, 2026 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Apr 14, 2026 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| MRW | System, Facet Screw Spinal Device | Unclassified | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Apr 14, 2026 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Apr 14, 2026 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| OWI | Bone Fixation Cerclage, Sublaminar | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| PEK | Spinous Process Plate | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |
| PML | Bone Cement, Posterior Screw Augmentation | Class II | Orthopedic | Contract manufacturing | Apr 14, 2026 |