ADHEAR 39608

GUDID 09008737396084

ADHEAR Headband, pink, bilateral

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

Head-worn bone-conduction hearing aid

• Primary Device ID: 09008737396084
• NIH Device Record Key: fd853482-f077-4af0-80ab-5a430170c6ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADHEAR
• Version Model Number: 39608
• Catalog Number: 39608
• Company DUNS: 300764032
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008737396084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172460

FDA Product Code

• LXB: Hearing Aid, Bone Conduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2019-11-08

On-Brand Devices [ADHEAR]

• 09008737396091: ADHEAR Headband, blue, bilateral
• 09008737396084: ADHEAR Headband, pink, bilateral
• 09008737396077: ADHEAR Headband, beige, bilateral
• 09008737396060: ADHEAR Headband, black, bilateral
• 09008737382032: ADHEAR User Kit, Terra Brown
• 09008737382025: ADHEAR User Kit, Dove Silver
• 09008737382018: ADHEAR User Kit, Simply Black
• 09008737382001: ADHEAR Professional Kit
• 09008737381998: ADHEAR Professional Kit
• 09008737381981: ADHEAR User Kit, Terra Brown
• 09008737381974: ADHEAR User Kit, Dove Silver
• 09008737381967: ADHEAR User Kit, Simply Black
• 09008737522759: ADHEAR Configuration Software 1.0 DVD
• 09008737363635: ADHEAR Configuration Software 1.0 USB
• 09008737359454: ADHEAR User Kit, Terra Brown/beige
• 09008737359447: ADHEAR User Kit, Terra Brown/brown
• 09008737359430: ADHEAR User Kit, Dove Silver/beige
• 09008737359423: ADHEAR User Kit, Dove Silver/brown
• 09008737359416: ADHEAR User Kit, Simply Black/beige
• 09008737359409: ADHEAR User Kit, Simply Black/brown
• 09008737359393: ADHEAR Professional Kit, Test/beige
• 09008737359386: ADHEAR Professional Kit, Test/brown
• 09008737353261: ADHEAR Headband, blue
• 09008737353254: ADHEAR Headband, pink
• 09008737353247: ADHEAR Headband, beige
• 09008737347376: ADHEAR Professional Kit, Test/beige
• 09008737347369: ADHEAR Professional Kit, Test/brown
• 09008737347352: ADHEAR User Kit, Terra Brown/beige
• 09008737347345: ADHEAR User Kit, Terra Brown/brown
• 09008737347338: ADHEAR User Kit, Dove Silver/beige
• 09008737347321: ADHEAR User Kit, Dove Silver/brown
• 09008737347314: ADHEAR User Kit, Simply Black/beige
• 09008737347307: ADHEAR User Kit, Simply Black/brown
• 09008737346911: ADHEAR Headband, black
• 09008737346904: ADHEAR Adhesive Adapters, brown, 15 pcs.
• 09008737346898: ADHEAR Adhesive Adapters, beige, 15 pcs.
• 09008737346881: ADHEAR Audio Processor, Model 701, Test Device
• 09008737346874: ADHEAR Audio Processor, Model 701, Terra Brown
• 09008737346867: ADHEAR Audio Processor, Model 701, Dove Silver
• 09008737346850: ADHEAR Audio Processor, Model 701, Simply Black
• 09008737404338: ADHEAR 701, Test Device, lock
• 09008737404321: ADHEAR 701, Terra Brown, lock
• 09008737404314: ADHEAR 701, Dove Silver, lock
• 09008737404307: ADHEAR 701, Simply Black, lock
• 09008737382087: ADHEAR Configuration Software 1.0 Download