FDA.reportPublic FDA data

BALLOON SHEATH

Primary DI
04953170365126
Brand
BALLOON SHEATH
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MH-246R
Catalog number
N5377830
Device description
This model includes one of connector section and five of insertion sections. The connector section is reusable and requires autoclave sterilization prior to use. The insertion section is single-use and packaged as sterile. Please refer to the instruction manual for details.
Published
2016-09-21
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
FEDendoscopic access overtube, gastroenterology-urology
ODGEndoscopic ultrasound system, gastroenterology-urology

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170365123PackageGS15In Commercial Distribution
04953170365126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317036512314953170365123
04953170365126049531703651264953170365126

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
Premarket exempt
false
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
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

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
10884450457372C2 CryoBalloon™Merit Medical Systems, Inc.FED2026-08-21
06973356551462ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551479ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551493ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551509ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551660ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551677ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551684ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551691ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18