FDA.reportPublic FDA data

ANTS Electrode

Primary DI
09008737371371
Brand
ANTS Electrode
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
37137
Device description
Diagnostic Electrode
Published
2024-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MCMImplant, Cochlear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCMImplant, CochlearUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000025127

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000025127COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008737371371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737371371090087373713719008737371371

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear nerve function operative test electrodeAn invasive, hand-held, thin instrument (probe) with a distal electrode intended for preoperative and/or intraoperative delivery of electrical stimulation to the cochlear (auditory) nerve to assess nerve function prior to implantation of a cochlear implant (CI). It may be used during open surgery or via transtympanic approach and conducts electrical current via connection to an external electrical pulse generator; it is used in conjunction with an evoked auditory brainstem response (eABR) recording system. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the sterilized contents in this box at room temperature until the stated expiry date.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300764032
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09008737461379SONNET Battery Pack Cover Standard Pro, Anthracite461372026-02-26
09008737461386SONNET Battery Pack Cover Standard Pro, Ebony461382026-02-26
09008737461393SONNET Battery Pack Cover Standard Pro, Nordic Gray461392026-02-26
09008737461409SONNET Battery Pack Cover Standard Pro, Beige461402026-02-26
09008737461416SONNET Battery Pack Cover Standard Pro, White461412026-02-26
09008737461423SONNET Battery Pack Cover Standard Pro, Black461422026-02-26
09008737461485SONNET Battery Pack Cover Micro Pro, Anthracite461482026-02-26
09008737461492SONNET Battery Pack Cover Micro Pro, Ebony461492026-02-26
09008737461508SONNET Battery Pack Cover Micro Pro, Nordic Gray461502026-02-26
09008737461515SONNET Battery Pack Cover Micro Pro, Beige461512026-02-26
09008737461522SONNET Battery Pack Cover Micro Pro, White461522026-02-26
09008737461539SONNET Battery Pack Cover Micro Pro, Black461532026-02-26
09008737583262SoftGrip Forceps583262021-04-09
09008737415808Verifit Adapter415802025-11-17
09008737002848Surgical Claw angled002842014-09-22
09008737455712AudioLink XT Kit455712025-02-26
09008737458904AudioLink XT Core Kit458902025-02-26
09008737415433Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet41543415472024-10-15
09008737415440Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet41544415482024-10-15
09008737416218Insertion Electrode FLEX34416212024-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09008737461379SONNET Battery Pack Cover Standard Pro, AnthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461386SONNET Battery Pack Cover Standard Pro, EbonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461393SONNET Battery Pack Cover Standard Pro, Nordic GrayMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461409SONNET Battery Pack Cover Standard Pro, BeigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461416SONNET Battery Pack Cover Standard Pro, WhiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461423SONNET Battery Pack Cover Standard Pro, BlackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461485SONNET Battery Pack Cover Micro Pro, AnthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461492SONNET Battery Pack Cover Micro Pro, EbonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461508SONNET Battery Pack Cover Micro Pro, Nordic GrayMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461515SONNET Battery Pack Cover Micro Pro, BeigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461522SONNET Battery Pack Cover Micro Pro, WhiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461539SONNET Battery Pack Cover Micro Pro, BlackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
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