AccessGUDID - DEVICE: Earlens Processor & Ear Tip (00850013007233)

GUDID

Device Identifier (DI) Information

Brand Name: Earlens Processor & Ear Tip
Version or Model: PET01X
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PET01X
Company Name: EARLENS CORPORATION

Primary DI Number: 00850013007233
Issuing Agency: GS1
Commercial Distribution End Date: December 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 611658795 *Terms of Use

Device Description: Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, Ear Tip comes in L - Left, R - Right

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
62419	Tympanic membrane contact hearing aid sound processor	An electronic component of a tympanic membrane (TM) contact hearing aid designed to be wornbehind-the-ear (BTE) and to receive sound waves and convert them into electrical signals fortransmission to another component. The hearing aid is intended to compensate for mild/severesensorineural impaired hearing by transmitting transduced sound waves, via light waves orelectromagnetic energy, to a vibrator component in direct contact with the TM.	Active	false
62420	Tympanic membrane contact hearing aid ear tip transmitter	An electronic component of a tympanic membrane (TM) contact hearing aid intended to be placed inthe external auditory canal to convert electrical signals from a sound processor into light signals orelectromagnetic energy for transmission to another component. The hearing aid is intended tocompensate for mild/severe sensorineural impaired hearing by transmitting transduced soundwaves, via light waves or an oscillating electromagnetic field, to a vibrator component in directcontact with the TM; it may include a custom-made earmould in which it is held in place.	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 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: 25859da4-bc42-46f1-be82-e2f3a9b9abd9
Public Version Date: March 22, 2023
Public Version Number: 3
DI Record Publish Date: May 06, 2019