FDA.reportPublic FDA data

BALLOON3

Primary DI
04953170360442
Brand
BALLOON3
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-249
Published
2016-09-21
Public version status
Update
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
ODGEndoscopic ultrasound system, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODGEndoscopic Ultrasound System, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010591000OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTEROlympus Optical Co., Ltd.2001-03-15ODG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170360442PrimaryGS10
84953170360448Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170360442049531703604424953170360442
8495317036044884953170360448

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound endoscope balloon, Hevea-latexA sterile balloon-like cap made of Hevea natural rubber latex (NRL) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the 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
20
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926600PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926723PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826927010PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928307PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928444PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928567PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928574PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
00191506062620RIVOS™BOSTON SCIENTIFIC CORPORATIONODG2026-06-25
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.ODG2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.ODG2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.ODG2026-06-01
04953170467288ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.ODG2026-01-21
04953170467318ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.ODG2026-01-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.ODG2025-11-19
04953170467356EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180OLYMPUS MEDICAL SYSTEMS CORP.ODG2025-09-25
06932503534703Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30