FDA Registration
Active
🇰🇷 South Korea
CUSTOM TUBE MANUFACTURING LLC
Reg #: 3010966701
·
FEI: 3010966701
·
Expires 2026
Products
19
Proprietary Names
36
Establishment Types
1
Classifications
19
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Registration Details
- Registration Name
- CUSTOM TUBE MANUFACTURING LLC
- Registration Number
- 3010966701
- FEI Number
- 3010966701
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 38-4, Hyeonseok-ro 733beon-gil, Gwangjeok-myeon
- City
- Yangju-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- CUSTOM TUBE MANUFACTURING LLC
- Operator Number
- 10046953
- Address
- 38-4, Hyeonseok-ro 733beon-gil, Gwangjeok-myeon
- City
- Yangju-si
- State
- Gyeonggi
- Postal Code
- 11413
- Country
- KR
US Agent
- Business Name
- SPECTRA MEDICAL DEVICES, LLC
- Contact Name
- Kathy Dassler
- Address
- 299 BALLARDVALE STREET, SUITE 1
- City
- Wilmington
- State
- MA
- ZIP
- 01887
- Country
- US
- [email protected]
- Phone
- 978 6570889 ext. 5224
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2016-02-06 |
| Needle, Spinal, Short Term | MIA | Class 2 | Anesthesiology | No | 2014-06-04 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2014-10-07 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2014-06-04 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2014-10-07 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2015-01-26 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2014-06-04 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2018-04-23 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2024-04-01 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2021-11-17 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2014-06-04 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2014-06-04 |
| Needle, Gastro-Urology | FHR | Class 1 | General, Plastic Surgery | No | 2020-12-21 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2014-06-04 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2014-06-04 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2014-06-04 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2015-11-17 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2020-12-21 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2014-10-07 |
Proprietary Names
SPECTRA MSK Ultrasonic Injection Needle
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
SPINAL NEEDLE
Vascular Access Port Infusion Set
HUBER NEEDLE
Disposable Scalpel, One-Piece, Non-Sterile
Spectra Soft Tissue Biopsy Needles
SPECTRA GUIDE GLIDE II GUIDE WIRE INTRODUCER NEEDLE
GUIDE WIRE INTRODUCER NEEDLE
SPECTRA GUIDE GLIDE GUIDE WIRE INTRODUCER NEEDLE
Epidural Needle for Arrow Anesthesia Conduction Kit
Disposable Epidural Anesthesia Tray
NEEDLE, ASPIRATION AND INJECTION
BSC Insertion Needle (Component - bulk, nonsterile)
PENCIL POINT NEEDLE
SPECTRA SAFE-CUT SAFETY SCALPEL
Introducer Needle
SPECTRA Sonic Block Quincke Needle
SPECTRA Sonic Block Crawford Needle
SPECTRA Sonic Block Chiba Needle
SPECTRA Sonic Block Tuohy Needle
MANUAL INSTRUMENT
RADIOFREQUENCY NEEDLE
RF NEEDLE
TRUGUIDE COAXIAL BIOPSY NEEDLE
BLUNT TIP STYLET FOR TRUGUIDE NEEDLE
RF Cannulae
Cannula Assembly
RF Cannula
Radiofrequency Cannula
Glass Loss-of-Resistance Syringe
Spectra Glass LOR Syringe
SPECTRA TUOHY ULTRASONIC
SPECTRA CRAWFORD ULTRASONIC
SPECTRA HUSTEAD ULTRASONIC
EPIDURAL NEEDLE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)