FDA.reportPublic FDA data

AcuJect Flex

Primary DI
00816207021218
Brand
AcuJect Flex
Company
ENDO-THERAPEUTICS, INC.
Model
AJ FLEX 25 230 10
Catalog number
AJ FLEX 25 230 10
Device description
Endoscopic injection needle
Published
2019-12-03
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
10816207021215PackageGS110In Commercial Distribution
00816207021218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081620702121510816207021215
00816207021218008162070212188162070212180816207021218

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
Device Size Text, specify0
Device Size Text, specify0
Length230Centimeter
Needle Gauge25Gauge
Outer Diameter2.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
844-400-3636customerservice@endotherapeutics.com

Regulatory Flags#

DUNS number
825239189
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816207021775Biopsy BrushET1424ET14242026-10-07
00816207021782Biopsy BrushET1425ET14252026-10-07
00816207020006EndoTBasketET2031ET20312016-09-22
00816207020013EndoTBasketET2030ET20302016-09-22
00816207020020EndoTBasketET2033ET20332016-09-22
00816207020037EndoTBasketET2032ET20322016-09-22
00816207020044EndoTBasketET2035ET20352016-09-22
00816207020051EndoTBasketET2034ET20342016-09-22
00816207020068EndoTBasketET2040ET20402016-09-22
00816207020075EndoTBasketET2041ET20412016-09-22
00816207020082EndoTBasketET2043ET20432016-09-22
00816207020099EndoTBasketET2042ET20422016-09-22
00816207020112EndoTBasketET2045ET20452016-09-22
00816207020129EndoTBasketET2044ET20442016-09-22
00816207020334EndoTGrasperET2021ET20212016-09-22
00816207020341EndoTGrasperET2022ET20222016-09-22
00816207020952EndoTGrasperET2020ET20202022-09-21
00816207021027Single Use Brush Biopsy InstrumentEGD-160-006EGD-160-0062022-12-09
00816207021041Single Use Brush Biopsy InstrumentEGD-230-006EGD-230-0062022-12-09
00816207021690Single Use Brush Biopsy InstrumentTNE-110TNE-1102022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603212196ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212202ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212219ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212240ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212257ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212271ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212288ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212295ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
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