FDA.reportPublic FDA data

BALLOON3

Primary DI
04953170463921
Brand
BALLOON3
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-249
Catalog number
N5369531
Published
2025-02-25
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170463921PrimaryGS10
84953170463927Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170463921049531704639214953170463921
8495317046392784953170463927

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.

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
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
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06932503534727Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534734Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534741Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534772Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534789Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534819Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534826Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534864Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534888Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534700Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534724Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534731Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534748Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534779Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534786Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534816Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534823Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534861Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534885Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
04953170467271PROBE DRIVING UNITOLYMPUS MEDICAL SYSTEMS CORP.ODG2025-04-16
04961333253906PENTAXHOYA CORPORATIONODG2025-04-04
04961333253937PENTAXHOYA CORPORATIONODG2025-04-04