FDA.reportPublic FDA data

Single Use Injector

Primary DI
04953170453526
Brand
Single Use Injector
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
NM-400L-0625
Catalog number
N6139440
Published
2025-11-19
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252247000Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems Corporation2025-10-16FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170453523PackageGS15In Commercial Distribution
04953170453526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317045352314953170453523
04953170453526049531704535264953170453526

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21

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