FDA Registration
Active
🇺🇸 United States
Urology
Reg #: 3015895045
·
FEI: 3015895045
·
Expires 2025
Products
23
Proprietary Names
1
Establishment Types
1
Classifications
23
Registration Details
- Registration Name
- Sklar Corporation - Warehouse
- Registration Number
- 3015895045
- FEI Number
- 3015895045
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2015 Industrial Parkway
- City
- Salisbury
- State
- MD
- ZIP
- 21801
- Country
- US
Regulatory Submissions
- 510(k) Number
- K012660
Owner / Operator
- Firm Name
- Sklar Corporation
- Operator Number
- 10023634
- Address
- 1333 Lenape Rd.
- City
- West Chester
- State
- PA
- Postal Code
- 19382
- Country
- US
- Correspondent
- Douglas B Kraemer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Cholangiography | GBZ | Class 1 | General, Plastic Surgery | No | 2017-02-10 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2017-02-10 |
| Dislodger, Stone, Biliary | LQR | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2017-02-10 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Urethroscope | FGC | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Laparoscopy Kit | FDE | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2017-02-10 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | Class 1 | Gastroenterology, Urology | No | 2017-02-10 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Light Source, Endoscope, Xenon Arc | GCT | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2017-02-10 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
| Resectoscope, Working Element | FDC | Class 2 | Gastroenterology, Urology | No | 2017-02-10 |
Proprietary Names
Urology
Establishment Types
Repack or Relabel Medical Device