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
Phone
978 6570889 ext. 5224

Products

Device Name Product Code
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Needle, Spinal, Short Term MIA
Set, Administration, Intravascular FPA
Needle, Hypodermic, Single Lumen FMI
Scalpel, One-Piece GDX
Instrument, Biopsy KNW
Introducer, Catheter DYB
Anesthesia Conduction Kit CAZ
Needle, Aspiration And Injection, Disposable GAA
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
Handle, Scalpel GDZ
Blade, Scalpel GES
Needle, Gastro-Urology FHR
Instrument, Manual, Surgical, General Use MDM
Probe, Radiofrequency Lesion GXI
Generator, Lesion, Radiofrequency GXD
Biopsy Needle FCG
Guide, Needle, Surgical GDF
Syringe, Piston FMF

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)