Contract manufacturerPerformance Fibers OEM LLC (Mansfield, MA)MassachusettsCardiovascularGeneral and plastic surgeryOrthopedicClass II
Performance Fibers OEM LLC
Contract manufacturer ยท Mansfield, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1221601 (openFDA record; or search FDA's registration database)
- FEI number
- 1221601
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Performance Fibers OEM LLC (FDA owner/operator no. 10096269)
- Registered address
- 375 Forbes Blvd, Mansfield, MA 02048
- Contract listings
- 27 device listings, 13 product codes, first listed Aug 17, 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 |
|---|---|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | Class II | Cardiovascular | Contract manufacturing | Aug 17, 2026 |
| GAL | Suture, Absorbable, Natural | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2026 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2026 |
| GAN | Suture, Absorbable, Synthetic | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2026 |
| GAO | Suture, Nonabsorbable | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2026 |
| GAP | Suture, Nonabsorbable, Silk | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2026 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2026 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2026 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2026 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2026 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2026 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Aug 17, 2026 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2026 |