ADHEAR Headband, black, bilateral

Primary DI
09008737396060
Brand
ADHEAR Headband, black, bilateral
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
39606
Device description
Audio Processor Headband
Published
2019-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXBHearing Aid, Bone Conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXBHearing Aid, Bone ConductionEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172460000ADHEAR SystemMed-El Elektromedizinische Geraete GmbH2018-04-27LXB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008737396060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737396060090087373960609008737396060

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn hearing aid holder, reusableA device intended to be fixed/worn on a patient’s head to hold an air- or bone-conduction hearing aid; it may in addition be designed to hold a hearing aid dummy/counterbalance. It may be adhered to the skin, magnetically held in place on the side of the head by an implantable magnet (not included), attached to existing clothing (e.g., hat,) or spectacles, or worn like a headband. Dedicated devices (e.g., scale) used in the fitting process may be packaged with the holder. This is a reusable device.

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
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
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

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