AccessGUDID - DEVICE: SAMBA BB R, AP Unit (09008738517846)

GUDID

Device Identifier (DI) Information

Brand Name: SAMBA BB R, AP Unit
Version or Model: 51784
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008738517846
Issuing Agency: GS1
Commercial Distribution End Date: June 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Audio Processor

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFO	Implantable Bone Conduction Hearing Aid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN170009	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -25 and 60 Degrees Celsius
Handling Environment Temperature: between -13 and 140 Degrees Fahrenheit
Handling Environment Humidity: less than 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 60 Degrees Celsius
Storage Environment Temperature: between -13 and 140 Degrees Fahrenheit
Storage Environment Humidity: less than 93 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c0086b63-5b56-4e68-b061-ddf3b8d364d3
Public Version Date: June 24, 2024
Public Version Number: 4
DI Record Publish Date: October 05, 2018