GUDID 09008738500558

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Partially-implantable middle ear implant system ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use
Primary Device ID09008738500558
NIH Device Record Key7c3e6065-690f-493d-b56b-2e5618515961
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberVORP Sizer Kit
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
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

Customer Support Contacts

Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS109008738500558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPVImplant, Hearing, Active, Middle Ear, Partially Implanted

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-03
Device Publish Date2014-09-22

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