Contract manufacturerKENT ELASTOMER PRODUCTS, INC. (Dundee, OH)OhioGeneral and plastic surgeryClass IClass II
KENT ELASTOMER PRODUCTS, INC.
Contract manufacturer · Dundee, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3003502083 (openFDA record; or search FDA's registration database)
- FEI number
- 3003502083
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- KENT ELASTOMER PRODUCTS, INC. (FDA owner/operator no. 9044738)
- Registered address
- 7369 PEABODY-KENT RD., Dundee, OH 44624
- Contract listings
- 3 device listings, 3 product codes, first listed Jan 27, 2005
- 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 |
|---|---|---|---|---|---|
| GAX | Tourniquet, Nonpneumatic | Class I | General and plastic surgery | Contract manufacturing | Jan 27, 2005 |
| GBW | Catheter, Peritoneal | Class I | General and plastic surgery | Contract manufacturing | Sep 20, 2005 |
| PUI | Drape, Surgical, Exempt | Class II | General and plastic surgery | Contract manufacturing | Jan 16, 2023 |