AccessGUDID - DEVICE: Earlens Tympanic Lens, Binaural (00850013007257)

GUDID

Device Identifier (DI) Information

Brand Name: Earlens Tympanic Lens, Binaural
Version or Model: ITL01LR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ITL01LR
Company Name: EARLENS CORPORATION

Primary DI Number: 00850013007257
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 611658795 *Terms of Use

Device Description: Inductive Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this product box.

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?
62421	Tympanic membrane contact hearing aid tympanic transducer	An electronic component of a tympanic membrane (TM) contact hearing aid intended to be placed in direct contact with the TM and to convert signals into vibrations, which are then passed along the normal sound conduction pathway in the middle ear. The TM transducer is non-surgically placed by a healthcare professional in a clinical setting and is intended to remain in situ indefinitely. The hearing aid is intended to compensate for mild/severe sensorineural impaired hearing by transmitting transduced sound waves, via light waves or an oscillating electromagnetic field, to a vibrator component in direct contact with the TM.	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 [?]
K182480	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
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 525 and 795 Millimeter of Mercury
Storage Environment Temperature: between -20 and 50 Degrees Celsius
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: eb3aa179-f686-4409-b60f-016c1f65fe36
Public Version Date: June 12, 2023
Public Version Number: 4
DI Record Publish Date: May 06, 2019