FDA.reportPublic FDA data

FUJIFILM

Primary DI
04547410331028
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
EG-530WR
Device description
This device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of t
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
14547410331025PackageGS11In Commercial Distribution
04547410331028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454741033102514547410331025
04547410331028045474103310284547410331028

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video gastroduodenoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It can be end-viewing (looking forward) or side-viewing (looking to one side) and is used for the cannulation of the pancreas and bile duct. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00There must be no condensation.
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
High-level Disinfectant;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+018002728465xxx@xxx.xxx

Regulatory Flags#

DUNS number
713565195
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547410480269FUJIFILMVS-10002026-05-22
04547410529128FUJIFILMEG-S100XT2026-05-22
04573596200865APERTO LucentMR-JCR-82Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22
04573596200889APERTO LucentMR-JC-81Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200896APERTO LucentMR-JCR-83Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22
04573596200902APERTO LucentMR-CSC-81C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200940APERTO LucentMR-QWC-81Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter2026-05-22
04573596200964APERTO LucentMR-MSC-81Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E2026-05-22
04573596200971APERTO LucentMR-QRC-81Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E2026-05-22
04573596201480APERTO LucentMR-QHC-81RQD Head coil R MR-QHC-81R for APERTO Lucent2026-05-22
04573596201497APERTO LucentMR-QKC-83RQD Knee coil R MR-QKC-83R for APERTO Lucent2026-05-22
04573596201503APERTO LucentMR-IBC-83Open body coil MR-IBC-83 for APERTO Lucent/APERTO 2026-05-22
04573596202210APERTO LucentMR-QFC-82NFlexible Body coil N(M) MR-QFC-82N for APERTO Luce2026-05-22
04573596202227APERTO LucentMR-QFC-83NFlexible Body coil N(L) MR-QFC-83N for APERTO Luce2026-05-22
04547410571134FDR AQRODR-XD 1000 MBL ES US E2026-03-20
14547410566250FUJIFILMDH-084STR2026-02-27
14547410566298FUJIFILMDH-094STR2026-02-27
14547410566335FUJIFILMDH-104STR2026-02-27
14547410566373FUJIFILMDH-114STR2026-02-27
14547410566410FUJIFILMDH-124STR2026-02-27

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