S-Vector Magnet Replacement Kit 38234

GUDID 09008737382346

S-Vector Replacement Magnet (Ms010109) and Non-Magnetic Spacer (Ms010107)

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 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 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 ID09008737382346
NIH Device Record Keyf702870a-bc15-4f82-a442-edf3805a9d41
Commercial Distribution StatusIn Commercial Distribution
Brand NameS-Vector Magnet Replacement Kit
Version Model Number38234
Catalog Number38234
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

Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737382346 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-23
Device Publish Date2020-12-15

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