FDA.reportPublic FDA data

Single Use Cannula V

Primary DI
04953170466069
Brand
Single Use Cannula V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
PR-V416Q
Catalog number
N1088240
Published
2025-06-12
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
ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250573000Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614MOlympus Medical Systems Corp.2025-05-27ODD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170466066PackageGS11In Commercial Distribution
04953170466069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317046606614953170466066
04953170466069049531704660694953170466069

GMDN Terms#

Term, Definition table
TermDefinition
ERCP catheter, non-balloon, non-electrical, single-useA non-electrical flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). It is typically a single-lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization; it does not incorporate a balloon. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Expiration date on label
true
No 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
04953170466045Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466052Single 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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