UroPass Ureteral Access Sheath

GUDID 00821925035270

Gyrus Acmi, Inc.

Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter
Primary Device ID00821925035270
NIH Device Record Key4cc32b9a-8047-4597-93ed-a93e7e0acd77
Commercial Distribution StatusIn Commercial Distribution
Brand NameUroPass Ureteral Access Sheath
Version Model Number61324BX
Company DUNS007198742
Company NameGyrus Acmi, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925035270 [Package]
Contains: 00821925035430
Package: [5 Units]
In Commercial Distribution
GS100821925035430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNYACCESSORIES, CATHETER, G-U

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-10-03

On-Brand Devices [UroPass Ureteral Access Sheath]

0082192503530061354BX
0082192503529461346BX
0082192503528761338BX
0082192503527061324BX
0082192500599061254BX
0082192503525661246BX
0082192500598361238BX
0082192500597661224BX
0082192503522561154BX
0082192503521861146BX
0082192503520161138BX
0082192503519561124BX
0082192503518861054BX
0082192503517161046BX
0082192503516461038BX
0082192503515761024BX

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