BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

SAMBA BB L, AP Unit

DI: 09008738517839 · Model: 51783 · Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Brand Name: SAMBA BB L, AP Unit
Primary DI: 09008738517839
Version / Model: 51783
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Labeler DUNS: 300764032
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-10-05
Public Version: 4
Public Version Date: 2024-06-24
Public Version Status: Update
Public Device Record Key: 84a18f3c-d5d4-4a78-b779-96f4664bf42e
Distribution End Date: 2024-06-19

Device Description

Audio Processor

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Unsafe
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFO	Implantable Bone Conduction Hearing Aid	Ear, Nose, Throat	874.3340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62209	Bone-conduction hearing implant system sound processor/vibrator	An electrically-powered, external device intended to compensate for impaired hearing by receiving sound waves from the environment and converting them into vibrations, which are transmitted to the inner ear via the temporal bone. It typically incorporates a microphone, transmitter/receiver and vibrator connected or magnetically coupled to vibrating implantable components (e.g., vibration transmission screw, partially-implantable abutment) for retention and transmission of vibrations to the inner ear; it may include positioning and protection devices. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008738517839	GS1

Customer Contacts

Phone: +1(888)633-3527
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN170009	000

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: – 93 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -13 – 140 Degrees Fahrenheit
Type: Storage Environment Temperature
Temperature Range: -25 – 60 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: – 93 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: -13 – 140 Degrees Fahrenheit
Type: Handling Environment Temperature
Temperature Range: -25 – 60 Degrees Celsius