FDA Registration
Active
🇺🇸 United States
EXELINT INTERNATIONAL, CO.
Reg #: 1035907
·
FEI: 1035907
·
Expires 2026
Products
14
Proprietary Names
26
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- EXELINT INTERNATIONAL, CO.
- Registration Number
- 1035907
- FEI Number
- 1035907
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2500 Santa Fe Avenue
- City
- Redondo Beach
- State
- CA
- ZIP
- 90278
- Country
- US
Regulatory Submissions
- 510(k) Number
- K861152
Owner / Operator
- Firm Name
- EXELINT INTERNATIONAL, CO.
- Operator Number
- 10024414
- Address
- 2500 Santa Fe Ave
- City
- Redondo Beach
- State
- CA
- Postal Code
- 90278
- Country
- US
- Correspondent
- Stefanie Ng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2017-11-06 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2017-11-06 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2017-11-06 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2014-09-26 |
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2024-11-18 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2024-05-10 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2026-01-09 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2026-01-09 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2024-11-07 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2024-07-02 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2020-02-06 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2024-07-02 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2019-07-11 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2017-11-06 |
Proprietary Names
EXEL Multi Sample Blood Collecting Needle
Multiject Multi-Sample Luer Adapter
EXEL Luer Lock Holder with Pre-Attached Multi-Sample Sample Adapter
EXEL Injection Plug with Cap
EXEL Huber Needle
EXEL I.V. Extension Set
Exel Zorband Pressure Bandage
EXEL Multi-Sample Luer Holder
EXEL Catheter Tip Syringe
EXEL Curved Tip Syringe
EXEL Disposable Syringe with SecureTouch Safety Needle
EXEL Disposable Syringe with Needle
EXEL Hypodermic Needle
EXEL Disposable Syringe
EXEL 1ml Delivery Syringe
EXEL Surgical Blade
Comfortpoint Insulin Syringe
EXEL HUBER INFUSION SET WITHOUT (Y) INJECTION SITE
SecureTouch+ Safety Huber Infusion Set
SecureTouch Safety Scalp Vein Set
EXEL Disposable Scalpel
EXEL Aluminum Hub Blunt Needle
EXEL I.V. Administration Set
Superject Sterile Disposable Dental Needles
EXEL Huber Infusion Set with Needleless Injection Site
EXEL Spinal Needle
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device