FDA.reportPublic FDA data

UroPass

Primary DI
00821925035461
Brand
UroPass
Company
Gyrus ACMI, LLC
Model
61354BX
Device description
UroPass Ureteral Access Sheath 13/15 Fr (4.3/5 mm) x 54 cm (5/PK)
Published
2016-10-03
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

Product Codes#

Code, Name table
CodeName
KNYACCESSORIES, CATHETER, G-U

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNYAccessories, Catheter, G-UGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051593000UROPASS URETERAL ACCESS SHEATH, MODEL 61224Acmi Corporation2005-09-02KNY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925035300PackageGS15In Commercial Distribution
00821925035461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925035300008219250353008219250353000821925035300
00821925035461008219250354618219250354610821925035461

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral catheterA flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.

Regulatory Flags#

DUNS number
007198742
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
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10
00821925013032EVONOS1302042018-09-10
00821925013155EVONOS1302432018-09-10
00821925013285EVONOS1301352018-09-07
00821925013292EVONOS1301362018-09-07
00821925013308EVONOS1301372018-09-07
00821925013315EVONOS1301382018-09-07
00821925013612EVONOS1303132018-09-10
00821925013629EVONOS1303162018-09-10
00821925013827EVONOS1303652018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253027648DoverCardinal Health 200, LLCKNY2024-07-10
50192253032336DoverCardinal Health 200, LLCKNY2024-07-10
50192253027646DoverCardinal Health 200, LLCKNY2024-07-10
10192253032338DoverCardinal Health 200, LLCKNY2024-07-10
03700512966197Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cmPromeplaKNY2017-11-09
03700512966203Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cmPromeplaKNY2017-11-09
03700512966210Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cmPromeplaKNY2017-11-09
03700512966227Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cmPromeplaKNY2017-11-09
03700512986195Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cmPromeplaKNY2017-11-09
03700512986201Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cmPromeplaKNY2017-11-09
03700512986218Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cmPromeplaKNY2017-11-09
03700512986225Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cmPromeplaKNY2017-11-09
00821925036345VARI-PASSGyrus ACMI, LLCKNY2017-05-11
00821925027589VARI-PASS 10/12 Fr (3.3/4mm) x 54CMGyrus Acmi, Inc.KNY2017-05-11
10680651445787HalyardAvanos Medical, Inc.KNY2017-05-10
00821925035393UroPassGyrus ACMI, LLCKNY2016-10-12
00821925035409UroPass Gyrus ACMI, LLCKNY2016-10-12
00821925035423UroPassGyrus ACMI, LLCKNY2016-10-12
00821925005976UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
00821925005983UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
00821925005990UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
00821925035317UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035324GYRUS ACMI, INCGyrus ACMI, LLCKNY2016-10-03
00821925035331UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035348UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035355UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035362UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035379UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035386UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035416UroPassGyrus ACMI, LLCKNY2016-10-03