AccessGUDID - DEVICE: SAMBA 2 Lo PoM, right (09008737525361)

GUDID

Device Identifier (DI) Information

Brand Name: SAMBA 2 Lo PoM, right
Version or Model: 52536
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737525361
Issuing Agency: GS1
Commercial Distribution End Date:
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?
47369	Partially-implantable middle ear implant system sound processor	The non-sterile external portion of a partially-implantable middle ear implant system that typically consists of a battery-powered microphone, signal analysis and filtering unit, radio-frequency (RF) modulator and amplifier, and an RF transmitter and antenna. These components receive sound waves from the environment, convert them into electrical signals (radio waves), and transmit the signals to the implantable portion of the system which activates the auditory pathway by vibrating the ossicles (middle ear bones).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MPV	Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990052	026

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
Storage Environment Temperature: between -25 and 60 Degrees Celsius
Storage Environment Temperature: between -13 and 140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8afedeaf-75ed-4e2d-858c-d5d1aac882a2
Public Version Date: June 20, 2023
Public Version Number: 2
DI Record Publish Date: December 05, 2022