FDA.reportPublic FDA data

Injectra, ScleroTip

Primary DI
04052838009416
Brand
Injectra, ScleroTip
Company
Medi-Globe GmbH
Model
GSN-01-19-230
Catalog number
GSN-01-19-230
Device description
Injection Needle / Slerotherapy Needle , 22 Gauge, needle length 4 mm, tube diameter 1.9 mm, working length 230 cm
Published
2017-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052838009423PackageGS110In Commercial Distribution
04052838009416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052838009423040528380094234052838009423
04052838009416040528380094164052838009416

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge22Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep dry, keep away from sunlight

Contacts#

Phone, Email table
PhoneEmail
+4980329730sales@medi-globe.de

Regulatory Flags#

DUNS number
318130267
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052838002417Endoflux™GBS-01-07-0052026-08-27
04052838002424Endoflux™GBS-01-07-005S2026-08-27
04052838002431Endoflux™GBS-01-07-0062026-08-27
04052838002448Endoflux™GBS-01-07-0072026-08-27
04052838002455Endoflux™GBS-01-07-007S2026-08-27
04052838002462Endoflux™GBS-01-07-0092026-08-27
04052838002479Endoflux™GBS-01-07-009S2026-08-27
04052838002486Endoflux™GBS-01-07-0102026-08-27
04052838002493Endoflux™GBS-01-07-0112026-08-27
04052838002509Endoflux™GBS-01-07-0122026-08-27
04052838002516Endoflux™GBS-01-07-012S2026-08-27
04052838002523Endoflux™GBS-01-07-0142026-08-27
04052838002530Endoflux™GBS-01-07-0152026-08-27
04052838002547Endoflux™GBS-01-07-015S2026-08-27
04052838002554Endoflux™GBS-01-07-0162026-08-27
04052838002561Endoflux™GBS-01-08-0042026-08-27
04052838002578Endoflux™GBS-01-08-0052026-08-27
04052838002585Endoflux™GBS-01-08-005S2026-08-27
04052838002592Endoflux™GBS-01-08-0062026-08-27
04052838002608Endoflux™GBS-01-08-0072026-08-27

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