FDA.reportPublic FDA data

Sclerotherapy needle

Primary DI
06936534331010
Brand
Sclerotherapy needle
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-B-SY-2412-2308
Device description
without fixed button
Published
2022-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K212668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212668000Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd.2022-02-23FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936534331010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936534331010069365343310106936534331010

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Regulatory Flags#

DUNS number
544434963
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936534343020Disposable Ureteral StentsMD-D-JC-6F-26-S2026-09-22
06942804744602Single Use Ureteral Access SheathMD-A-AS-11522026-09-22
06942804744619Single Use Ureteral Access SheathMD-A-AS-11532026-09-22
06942804744626Single Use Ureteral Access SheathMD-A-AS-11542026-09-22
06942804744633Single Use Ureteral Access SheathMD-A-AS-11552026-09-22
06942804744640Single Use Ureteral Access SheathMD-A-AS-10362026-09-22
06942804744657Single Use Ureteral Access SheathMD-A-AS-10372026-09-22
06942804744664Single Use Ureteral Access SheathMD-A-AS-10382026-09-22
06942804744671Single Use Ureteral Access SheathMD-A-AS-10392026-09-22
06942804744688Single Use Ureteral Access SheathMD-A-AS-10402026-09-22
06942804744695Single Use Ureteral Access SheathMD-A-AS-10412026-09-22
06942804744701Single Use Ureteral Access SheathMD-A-AS-10422026-09-22
06942804744718Single Use Ureteral Access SheathMD-A-AS-10432026-09-22
06942804744725Single Use Ureteral Access SheathMD-A-AS-10442026-09-22
06942804744732Single Use Ureteral Access SheathMD-A-AS-10462026-09-22
06942804744749Single Use Ureteral Access SheathMD-A-AS-10472026-09-22
06942804744756Single Use Ureteral Access SheathMD-A-AS-10482026-09-22
06942804744763Single Use Ureteral Access SheathMD-A-AS-10492026-09-22
06942804744770Single Use Ureteral Access SheathMD-A-AS-10502026-09-22
06942804744787Single Use Ureteral Access SheathMD-A-AS-10512026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850002461388InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461395InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461418InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461425InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
00850002461404InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
00850002461435InjecSURE®Carbon Medical Technologies, Inc.FBK2026-04-09
03600040326893BoNeeColoplast A/SFBK2025-05-20
03600040974841BoNeeColoplast A/SFBK2025-05-20
00816734023365EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023372EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023389EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023396EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816207021256AcuJect FlexENDO-THERAPEUTICS, INC.FBK2023-07-11
04953170454011Single Use InjectorOLYMPUS MEDICAL SYSTEMS CORP.FBK2023-04-29
04953170454028Single Use InjectorOLYMPUS MEDICAL SYSTEMS CORP.FBK2023-04-29
04953170454035Single Use InjectorOLYMPUS MEDICAL SYSTEMS CORP.FBK2023-04-29
00860008483720Uro-N CystoscopeUROVIU CORP.FBK2022-12-16
00724995219185FastFloUS EndoscopyFBK2022-11-09
00724995219192FastFloUS EndoscopyFBK2022-11-09
00724995219208FastFloUS EndoscopyFBK2022-11-09
00724995219215FastFloUS EndoscopyFBK2022-11-09
00724995180881NAUS EndoscopyFBK2020-04-02
00724995180898NAUS EndoscopyFBK2020-04-02
00724995180904NAUS EndoscopyFBK2020-04-02
00724995180911NAUS EndoscopyFBK2020-04-02
00724995180928NAUS EndoscopyFBK2020-04-02
00724995180935NAUS EndoscopyFBK2020-04-02
00724995180942NAUS EndoscopyFBK2020-04-02
00724995180850ArticulatorUS EndoscopyFBK2020-04-01
00724995180867ArticulatorUS EndoscopyFBK2020-04-01