FDA.reportPublic FDA data

UroSeal

Primary DI
10724995211537
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
New
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
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
Endoscopic biopsy valve, single-useA device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
627879687
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00724995211530UroSealUS 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