Dornier HOOVER Access Sheath IVX-NB-150

GUDID 00810116023752

Hoover Urological Sampler Sets

DORNIER MEDTECH AMERICA, INC.

Ureteral introduction sheath
Primary Device ID00810116023752
NIH Device Record Key22da3b50-607b-4951-9d62-09f382b25165
Commercial Distribution StatusIn Commercial Distribution
Brand NameDornier HOOVER Access Sheath
Version Model NumberIVX-NB-150
Catalog NumberIVX-NB-150
Company DUNS130789944
Company NameDORNIER MEDTECH AMERICA, 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810116023752 [Primary]
GS100810116023769 [Package]
Package: [15 Units]
In Commercial Distribution

FDA Product Code

KDQBottle, Collection, Vacuum

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-22
Device Publish Date2026-01-14

On-Brand Devices [Dornier HOOVER Access Sheath]

00810116023752Hoover Urological Sampler Sets
00810116023653Hoover Negative Pressure Ureteral Access Sheath, 12Fr x 50 cm
00810116023646Hoover Negative Pressure Ureteral Access Sheath, 12Fr x 40 cm
00810116023639Hoover Negative Pressure Ureteral Access Sheath, 11Fr x 50 cm
00810116023622Hoover Negative Pressure Ureteral Access Sheath, 11Fr x 40 cm
00810116023615Hoover Negative Pressure Ureteral Access Sheath, 10Fr x 50 cm
00810116023608Hoover Negative Pressure Ureteral Access Sheath, 10Fr x 40 cm

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