FDA Registration
Active
🇺🇸 United States
URESIL, LLC
Reg #: 1450395
·
FEI: 1450395
·
Expires 2026
Products
8
Proprietary Names
13
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- URESIL, LLC
- Registration Number
- 1450395
- FEI Number
- 1450395
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5418 WEST TOUHY AVE.
- City
- SKOKIE
- State
- IL
- ZIP
- 60077
- Country
- US
Regulatory Submissions
- 510(k) Number
- K980889
Owner / Operator
- Firm Name
- URESIL, LLC
- Operator Number
- 9021454
- Address
- 5418 WEST TOUHY AVE., --
- City
- Skokie
- State
- IL
- Postal Code
- 60077
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2014-08-26 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2010-12-13 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 1997-10-17 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 1992-06-18 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2017-02-28 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2017-10-12 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2010-12-13 |
| Bag, Bile Collecting | EXF | Class 2 | Gastroenterology, Urology | No | 2021-11-19 |
Proprietary Names
NEPHRO-STENT Nephro-ureteral Stent Catheter
Chole-Cath
TRU-FIX CATHETER FIXATION KIT
TRU-CLOSE Suction Drainage System
TRU-CLOSE ASPIRATION
Posi-Stick Introducer Set
Symphony Centesis Drainage Catheter
Thora-Vent
Ulti-Flo General Purpose Drainage Catheter
Aspiration and Flush Assembly
GP General Purpose Drainage Catheter
Nephro-Cath Nephrostomy Drainage Catheter
Optimus
Establishment Types
Manufacture Medical Device