FDA.reportPublic FDA data

Olympus

Primary DI
14953170035255
Brand
Olympus
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-65
Published
2018-09-21
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
GDMNEEDLE, ASPIRATION AND INJECTION, REUSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170035255PackageGS16In Commercial Distribution
04953170035258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317003525514953170035255
04953170035258049531700352584953170035258

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
true
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
24026704934595PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934601PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934618PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
D928106122R450SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLEW.H. Holden, Inc.GDM2026-01-15
04059453120823Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-12-05
04059453124135Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-08-25
00810130455386Medco ManufacturingMedco Manufacturing LLCGDM2025-08-07
00810130455393Medco ManufacturingMedco Manufacturing LLCGDM2025-08-07
00194613120238MSI Precision Specialty InstrumentsMed Saver, Inc.GDM2025-08-01
00810130455300Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455317Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455324Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455331Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455218Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455225Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455232Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455164Medco ManufacturingMedco Manufacturing LLCGDM2025-06-17
00810130455140Medco ManufacturingMedco Manufacturing LLCGDM2025-06-10
00190776401139MillenniumAvalign Technologies, Inc.GDM2025-06-09
D92810613410SUCTION TIP THREADED #4 W/ HOLEW.H. Holden, Inc.GDM2025-05-21
00810130455003Medco ManufacturingMedco Manufacturing LLCGDM2025-05-06
00192896121492Heparin Olive Tip Needle CannulaSONTEC INSTRUMENTS, INC.GDM2025-04-22
00810130454976Medco ManufacturingMedco Manufacturing LLCGDM2025-04-04
00810130454907Medco ManufacturingMedco Manufacturing LLCGDM2025-03-27
00840516142685Anodyne SurgicalPsi/Eye-Ko, Inc.GDM2025-02-28
00819127023515Tulip Medical Products Reusable CannulasTulip Medical ProductsGDM2025-02-05
00810130454662Medco ManufacturingMedco Manufacturing LLCGDM2024-12-19
00810130454631Medco ManufacturingMedco Manufacturing LLCGDM2024-12-18
D928106121D450SUCTION TIP #1 REGULAR, 9 IN. LENGTH, 1MM, 45 DEGREE DOWN GRINDW.H. Holden, Inc.GDM2024-12-18
D928106121HV20SUCTION TIP #1 HI VOLUME B-STYLE, 9 IN. LENGTH, 1MMW.H. Holden, Inc.GDM2024-12-18