FDA.reportPublic FDA data

OLYMPUS

Primary DI
14953170422604
Brand
OLYMPUS
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
NM-400U-0623
Device description
Single Use Injector
Published
2020-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
14953170422604PackageGS15In Commercial Distribution
54953170422602PackageGS18In Commercial Distribution
04953170422607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317042260414953170422604
5495317042260254953170422602
04953170422607049531704226074953170422607

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
14953170467377SINGLE USE DISTAL COVERMAJ-2315N61920012026-03-06
04953170467288ULTRASONIC PROBEUM-3R-3N53871402026-01-21
04953170467318ULTRASONIC PROBEUM-G20-29R-3N53872402026-01-21
14953170466219Single Use Cytology Brush VBC-V600P-3010N36258402026-01-19
14953170466349Single Use 3-Lumen Needle Knife VKD-V441MN54207402025-12-18
14953170466356Single Use 3-Lumen Needle Knife VKD-V451MN54208402025-12-18
04953170465277AUXILIARY WATER TUBEMAJ-855N34993402025-12-05
04953170421815Reusable Cordless TransducerTD-410N61329402025-12-04
14953170439992THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cmTB2-0520FCR50010082025-12-04
14953170440004THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cmTB2-0525FCR50010092025-12-04
14953170440011THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cmTB2-0535FCR50010102025-12-04
14953170440028THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cmTB2-0545FCR50010112025-12-04
04953170442353ULTRASONIC BIPOLAR GENERATORUSG-410N61924402025-12-04
04953170442445Update Tool for USG-410MAJ-2467N61925402025-12-04
14953170459204Single-use Fine Needle Biopsy (FNB) Device NA-U210HNA-U210H-8019N62211302025-12-02
14953170459259Single-use Fine Needle Biopsy (FNB) Device NA-U210HNA-U210H-8022N62213302025-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800035704711CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704728CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704841CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704858CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704865CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704872CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704889CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704896CORE-INJECTORINCORE CO., LTDFBK2026-02-06
06974296705915AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296706004AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296706479AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707131AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707285AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707377AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707315AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707322AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707339AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707346AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707353AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707360AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06942127812477AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06942127815362AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671385963AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671385994AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671386144AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671386175AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
05420051305209G-FlexG-Flex EuropeFBK2025-06-02
05420051305216G-FlexG-Flex EuropeFBK2025-06-02
05420051305247G-FlexG-Flex EuropeFBK2025-06-02
05420051306008G-FlexG-Flex EuropeFBK2025-06-02