FDA Registration
Active
🇺🇸 United States
RETRACTABLE TECHNOLOGIES, INC.
Reg #: 1647137
·
FEI: 1000306068
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- RETRACTABLE TECHNOLOGIES, INC.
- Registration Number
- 1647137
- FEI Number
- 1000306068
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 511 Lobo Ln
- City
- Little Elm
- State
- TX
- ZIP
- 75068
- Country
- US
Regulatory Submissions
- 510(k) Number
- K946219
Owner / Operator
- Firm Name
- RETRACTABLE TECHNOLOGIES, INC.
- Operator Number
- 9010273
- Address
- 511 LOBO LN., --
- City
- Little Elm
- State
- TX
- Postal Code
- 75068
- Country
- US
- Correspondent
- Michele - Larios
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2011-03-28 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2011-03-28 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2009-11-12 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2007-11-08 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2021-04-13 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2013-09-06 |
Proprietary Names
VanishPoint Syringe
Patient Safe Luer Cap
VanishPoint IV Catheter
VanishPoint Blood Collection Tube Holder
Patient Safe Syringe
EasyPoint Blood Collection Plus
VanishPoint Blood Collection Set
EasyPoint Needle
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device