AccessGUDID - DEVICE: Remote Control (09008737527969)

GUDID

Device Identifier (DI) Information

Brand Name: Remote Control
Version or Model: 52796
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737527969
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Audio Processor Remote Control

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?
57885	Hearing aid/implant system remote control	A battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFO	Active Implantable Bone Conduction Hearing System
MPV	Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN170009	000
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
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -29 and 60 Degrees Celsius
Handling Environment Temperature: between -20.2 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -29 and 60 Degrees Celsius
Storage Environment Temperature: between -20.2 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c6ac5714-f0a8-4823-a4ed-3638c0014f30
Public Version Date: November 14, 2022
Public Version Number: 4
DI Record Publish Date: September 08, 2020