FDA.reportPublic FDA data

SONNET Battery Pack Cover Standard Pro, Black

Primary DI
09008737461423
Brand
SONNET Battery Pack Cover Standard Pro, Black
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
46142
Device description
Audio Processor Battery Pack Cover
Published
2026-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCMImplant, Cochlear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCMImplant, CochlearUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008737461423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737461423090087374614239008737461423

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid/implant system sound processor/coil decorative coverA device intended to be used as an aesthetic (decorative) cover for the sound processor and/or coil (not included) of a hearing aid (e.g., bone-conduction) or hearing implant system (e.g., cochlear, bone-conduction, partially-implantable middle ear, auditory brainstem); some types may be designed to replace a section of the existing processor/coil housing and therefore additionally function as a dust-cover. It is typically made of plastic material (e.g., polystyrene) designed to be clipped onto the sound processor/coil; it is available in a variety of colours/designs. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1-888-633-3524implants.us@medel.com

Regulatory Flags#

DUNS number
300764032
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09008737346898ADHEAR Adhesive Adapters, beige, 15 pcs.346892018-06-27
09008737346904ADHEAR Adhesive Adapters, brown, 15 pcs.346902018-06-27
09008737346911ADHEAR Headband, black346912018-06-27
09008737353247ADHEAR Headband, beige353242018-06-27
09008737353254ADHEAR Headband, pink353252018-06-27
09008737353261ADHEAR Headband, blue353262018-06-27
09008737396060ADHEAR Headband, black, bilateral396062019-11-08
09008737396077ADHEAR Headband, beige, bilateral396072019-11-08
09008737396084ADHEAR Headband, pink, bilateral396082019-11-08
09008737396091ADHEAR Headband, blue, bilateral396092019-11-08
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840094413061Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094414891Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094419810Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094421783Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094427433Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094431072Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094433663Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094433687Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094433908Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094433953Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434011Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434073Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434103Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434134Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434202Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094435414Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445499Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445505Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445512Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445574Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094467033Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094467064Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094468924Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094480643Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094481138Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094481510Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094482548Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094483811Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094486362Naida CI M90Advanced Bionics, LLCMCM2026-10-22
00840094486379Naida CI M90Advanced Bionics, LLCMCM2026-10-22