FDA.reportPublic FDA data

UroSeal

Primary DI
00724995211530
Brand
UroSeal
Company
US Endoscopy
Model
00913410
Catalog number
00913410
Device description
The UroSeal Adjustable Endoscopic Valve is used to resist the backflow of fluid around an instrument inserted through the working channel of a ureteroscope or cystoscope.
Published
2022-11-28
Public version status
Update
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
EYKCONNECTOR, URETERAL CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYKConnector, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995211537PackageGS15In Commercial Distribution
00724995190767PreviousGS10
00724995211530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499521153710724995211537
00724995190767007249951907677249951907670724995190767
00724995211530007249952115307249952115300724995211530

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
Premarket exempt
true
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
05906168942235Sealing Connector Y pieceWISMED PL SP Z O OEYK2025-03-17
05906168942242Sealing Connector I Piece WISMED PL SP Z O OEYK2025-03-17
05906168942259Sealing Connector T pieceWISMED PL SP Z O OEYK2025-03-17
08714729298151NABOSTON SCIENTIFIC CORPORATIONEYK2024-10-09
10724995211537UroSealUS EndoscopyEYK2022-11-28
00827002142251CookCOOK INCORPORATEDEYK2020-10-02
00827002145290CookCOOK INCORPORATEDEYK2020-10-02
00827002162198CookCOOK INCORPORATEDEYK2020-10-02
00827002171077CookCOOK INCORPORATEDEYK2020-10-02
00850005780168GU TekV L V ASSOCIATES (INC)EYK2020-07-15
08714729010944NABOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010951NABOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729012832NABOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010975ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010982ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010999ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729011002ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24