FDA.reportPublic FDA data

CANNULA

Primary DI
04953170043161
Brand
CANNULA
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
PR-2B-1
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODDEndoscopic retrograde cholangiopancreatography (ERCP) cannula

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) CannulaGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170043168PackageGS11In Commercial Distribution
04953170043161PrimaryGS10
84953170043167Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317004316814953170043168
04953170043161049531700431614953170043161
8495317004316784953170043167

GMDN Terms#

Term, Definition table
TermDefinition
Tracheobronchial contrast medium catheterA flexible tube designed to be introduced into the tracheobronchial tree for the injection of contrast medium. It typically consists of a single lumen and an irrigation port, and is introduced via the oral cavity with a flexible endoscope. This is a reusable 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
2
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
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
04953170466045Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466052Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466069Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466076Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466083Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466090Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466106Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466113Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466120Single Use 2-Lumen Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466042Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466059Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466066Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466073Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466080Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466097Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466103Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466110Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466127Single Use 2-Lumen Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
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