FDA.reportPublic FDA data

Disposable Sclerotherapy Needle

Primary DI
00813353010271
Brand
Disposable Sclerotherapy Needle
Company
Telemed Systems
Model
2018
Device description
Sure-Stop Sclerotherapy Needle25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 160cm Working Length
Published
2023-08-24
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
K901437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901437000TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLETelemed Systems, Inc.1990-06-18FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813353010271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813353010271008133530102718133530102710813353010271

GMDN Terms#

Term, Definition table
TermDefinition
Sclerotherapy endoscopic needle, single-useA device intended to be used with an appropriate endoscope to inject a pharmaceutical into mucosa or a vessel during sclerotherapy (a treatment that involves injecting varicose veins with a sclerosing fluid). It is in the form of a flexible tube with a needle at the distal end and a syringe connector at the proximal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017939239
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813353010080Disposable Sure-Flex Biliary Balloon Dilatation Catheter13422023-07-12
00813353010097Disposable Sure-Flex Biliary Balloon Dilatation Catheter13442023-07-12
00813353010103Disposable Sure-Flex Biliary Balloon Dilatation Catheter13462023-07-12
00813353010110Disposable Progressive Pressure Dilators14152023-07-12
00813353010127Disposable Progressive Pressure Dilators14182023-07-12
00813353010196Disposable Sclerotherapy Needle20022023-08-24
00813353010202Disposable Sclerotherapy Needle20042023-08-24
00813353010219Disposable Sclerotherapy Needle20062023-08-24
00813353010226Disposable Sclerotherapy Needle20082023-08-24
00813353010233Disposable Sclerotherapy Needle20102023-08-24
00813353010240Disposable Sclerotherapy Needle20142023-08-24
00813353010257Disposable Sclerotherapy Needle20152023-08-24
00813353010264Disposable Sclerotherapy Needle20162023-08-24
00813353010288Disposable Transbronchial Needle21022023-08-24
00813353010295Disposable Gastrointestinal Cytology Brush30022023-08-24
00813353010301Disposable Gastrointestinal Cytology Brush30042023-08-24
00813353010318Disposable Gastrointestinal Cytology Brush30062023-08-24
00813353010325Disposable Gastrointestinal Cytology Brush30082023-08-24
00813353010332Disposable Gastrointestinal Cytology Brush30102023-08-24
00813353010349Disposable Gastrointestinal Cytology Brush30122023-08-24

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
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
00724995180874ArticulatorUS EndoscopyFBK2020-04-01
00724995180782iSnareUS EndoscopyFBK2020-03-19
00724995180799iSnareUS EndoscopyFBK2020-03-19