FDA.reportPublic FDA data

UroSeal

Primary DI
00724995190767
Brand
UroSeal
Company
US Endoscopy
Model
00913410
Catalog number
00913410
Device description
The UroSeal adjustable endoscopic valve is used to cover the opening to the biopsy/suction channel of an endoscope. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.
Published
2020-04-02
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995190764PackageGS15Not in Commercial Distribution
00816765012482PreviousGS10
00724995190767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499519076410724995190764
00816765012482008167650124828167650124820816765012482
00724995190767007249951907677249951907670724995190767

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope working-channel valve, single-useA device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

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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