Contract manufacturerWacker Silicone Manufactured Innovations LLC (Allentown, PA)PennsylvaniaGeneral and plastic surgeryClass I
Wacker Silicone Manufactured Innovations LLC
Contract manufacturer ยท Allentown, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3031481777 (openFDA record; or search FDA's registration database)
- FEI number
- 3031481777
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Wacker Silicone Manufactured Innovations LLC (FDA owner/operator no. 10091011)
- Registered address
- 999 Postal Rd, Allentown, PA 18109
- Contract listings
- 2 device listings, 2 product codes, first listed Jun 15, 2024
- 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 |
|---|---|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | Class I | General and plastic surgery | Contract manufacturing | Jun 15, 2024 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | Class I | General and plastic surgery | Contract manufacturing | Jun 15, 2024 |