FDA.reportPublic FDA data

Olympus

Primary DI
14953170214049
Brand
Olympus
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
K-012
Device description
DISPOSABLE EMR KIT
Published
2018-09-21
Public version status
Update
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
FDSGastroscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170214049PackageGS11In Commercial Distribution
04953170214042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317021404914953170214049
04953170214042049531702140424953170214042

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. 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
true
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
04547410529128FUJIFILMFUJIFILM CORPORATIONFDS2026-05-22
14547410566250FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
14547410566298FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
14547410566335FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
14547410566373FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
14547410566410FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
14547410566458FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
00850458007195GripTract-GI Endoscopic Tissue ManipulatorACTUATED MEDICAL, INC.FDS2025-12-23
14547410477150FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04953170423628GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-26
14953170454353DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-13
14953170454278DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
14953170454285DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
14953170454292DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
14953170454308DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
14953170454322DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
14953170454346DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-12
04961333129492PENTAXHOYA CORPORATIONFDS2025-04-04
04961333211692PENTAXHOYA CORPORATIONFDS2025-04-04
04961333251070PENTAXHOYA CORPORATIONFDS2025-04-04
14547410532873FUJIFILMFUJIFILM CORPORATIONFDS2024-12-20
04961333356393PENTAX MedicalHOYA CORPORATIONFDS2024-12-13
04961333356416PENTAX MedicalHOYA CORPORATIONFDS2024-12-13
04953170452475EVIS EXERA III GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2024-10-04
14547410500643FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
04547410517330FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
14547410528265FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
00850031897076Single-Use Gastroscope 3.5/2.0 85cmEvoendo, Inc.FDS2024-08-30
00850031897083Single-Use Gastroscope 3.5/2.0 85cm 5-packEvoendo, Inc.FDS2024-08-30
00850031897090Single-Use Gastroscope 3.5/2.0 85cm DEMOEvoendo, Inc.FDS2024-08-30