AccessGUDID - DEVICE: Earlens Light Driven Hearing Aid, Monaural, Right (08500130070147)

GUDID

Device Identifier (DI) Information

Brand Name: Earlens Light Driven Hearing Aid, Monaural, Right
Version or Model: MKEL1R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MKEL1R
Company Name: EARLENS CORPORATION

Primary DI Number: 08500130070147
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 611658795 *Terms of Use

Device Description: Kit containing Right Light Tip & Processor Assembly, Right Tympanic Lens, Charger. Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown

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:	Yes
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?
62418	Tympanic membrane contact hearing aid	A collection of electronic devices intended to compensate for mild/severe sensorineural impairedhearing by transmitting transduced sound waves, either via light waves or an oscillatingelectromagnetic field, to a vibrator component in direct contact with the tympanic membrane (TM). Itconsists of a behind-the-ear (BTE) sound processor that receives sound waves and converts theminto electrical signals, which are relayed to a light transducer or transmission coil in the external earcanal where they are converted into light or electromagnetic signals, which are transmittedto a transducer on the TM where they are converted to vibrations.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PLK	Tympanic Membrane Direct Contact Hearing Aid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 -20 and 50 Degrees Celsius
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 525 and 795 Millimeter of Mercury
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 525 and 795 Millimeter of Mercury

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c9b0fe9-f358-48c7-b5b5-0efe155cdfb5
Public Version Date: January 31, 2020
Public Version Number: 8
DI Record Publish Date: September 24, 2016