ANTS Electrode

GUDID 09008737371371

Diagnostic Electrode

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

Cochlear nerve function operative test electrode
Primary Device ID09008737371371
NIH Device Record Keyf46c3119-f8c3-4766-9183-665b4159fe44
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTS Electrode
Version Model Number37137
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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.
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
GS109008737371371 [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 Date2024-11-01
Device Publish Date2024-10-24

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