soudon

Primary DI
06975137042244
Brand
soudon
Company
Zhejiang Soudon Medical Technology Co., Ltd
Model
SD-04-B2323-6
Device 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.
Published
2026-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FBKEndoscopic Injection Needle, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232442000Disposable Endoscope Injection NeedlesZhejiang Soudon Medical Technology Co., Ltd.2023-11-09FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975137042244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975137042244069751370422446975137042244

GMDN Terms#

Term, Definition table
TermDefinition
Oesophagus brachytherapy system applicator, manualA 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.

Regulatory Flags#

DUNS number
724990005
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Company table
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