Inner Ear Valved Shunt

GUDID 00815347023588

Arenberg Inner Ear Valve Shunt

HOOD, E BENSON LABORATORIES INC

Nasopharyngeal airway, single-use
Primary Device ID00815347023588
NIH Device Record Key9714f4bb-4116-4a46-a391-f927ff1ef9ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameInner Ear Valved Shunt
Version Model NumberEA-1001
Company DUNS076603380
Company NameHOOD, E BENSON LABORATORIES INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS100815347023588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ESZTube, Shunt, Endolymphatic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023588]

Moist Heat or Steam Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-07

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