Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet 41547

GUDID 09008737415433

Cochlear Implant

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

Cochlear implant system
Primary Device ID09008737415433
NIH Device Record Keyc36dc149-b821-4b75-9c4e-dec61fb9daeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet
Version Model Number41543
Catalog Number41547
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 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
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
GS109008737415433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-23
Device Publish Date2024-10-15

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