FDA Registration
Active
🇺🇸 United States
MGEL BODY DISCS 63.5MM ROUND (2.5")
Reg #: 3005621376
·
FEI: 3005621376
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- POLYGEL LLC.
- Registration Number
- 3005621376
- FEI Number
- 3005621376
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Danforth Drive
- City
- Palmer TWP
- State
- PA
- ZIP
- 18045
- Country
- US
Owner / Operator
- Firm Name
- POLYGEL LLC.
- Operator Number
- 9080190
- Address
- 1 Danforth Dr., --
- City
- Palmer
- State
- PA
- Postal Code
- 18045
- Country
- US
- Correspondent
- LAWRENCE - KERSEN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2006-03-30 |
Proprietary Names
MGEL BODY DISCS 63.5MM ROUND (2.5")
MGEL BODY PADS - 102MM (4")
SGEL SELF ADHESIVE TRIM TO FIT WITH CLEAR TOP COVER
MGEL CARPAL GEL PADS
CGS THIN FOREFOOT GEL PAD
GELSMART M-GEL BODY PAD ADHESIVE SQUARES 10CM PAIR
UGEL SELF ADHESIVE EXTRA THIN GEL SHEET
MGEL CARPAL GEL SLEEVE WITH PAD
GELSMART M-GEL BODY PAD NON ADH SQUARES 10CM
ADHESIVE SGEL SHEET - TRIM TO FIT WITH ANTI-MICROBIAL TOP COVER
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility