RenaNav Single-Use Digital Flexible Ureteroscope

GUDID 00810024670109

Single-use digital flexible ureteroscope

CENTERPOINT SYSTEMS LLC

Flexible video ureteroscope, single-use
Primary Device ID00810024670109
NIH Device Record Key39b3c0ad-992a-433d-aca7-158e674ee0d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameRenaNav Single-Use Digital Flexible Ureteroscope
Version Model NumberNVS-MD-000334
Company DUNS117126091
Company NameCENTERPOINT SYSTEMS LLC
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810024670109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGBUreteroscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-23
Device Publish Date2024-04-15

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