Device
A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the oesophagus. It is an individual or modular device designed to facilitate m...
Manufacturer
Zhejiang Soudon Medical Technology Co., Ltd
Zhejiang Soudon Medical Technology Co., Ltd
Model: SD-04-B2323-6
DI: 06975137042244
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the oesophagus. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site within the oesophagus. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes oesophageal applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1b8f1254-ea62-4ee3-b4b6-97107384d31c
Distribution Status:
In Commercial Distribution
DUNS Number:
724990005
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06975137042244
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38420
Name: Oesophagus brachytherapy system applicator, manual
Definition:
A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the oesophagus. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site within the oesophagus. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes oesophageal applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.
FDA Product Codes
FBK
Endoscopic Injection Needle, Gastroenterology-Urology
Premarket Submissions
Submission Number:
K232442
Supplement Number:
000