GUDID 09008737096939

Replacement Magnet and Non-Magnetic Spacer

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

Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet Cochlear implant dummy magnet 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 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 ID09008737096939
NIH Device Record Key8c0625e9-8bb4-4d58-859c-87bbda00f44a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberMagnet Replacement Kit
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
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
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
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 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737096939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMIMPLANT, COCHLEAR

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-28
Device Publish Date2015-02-28

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