AccessGUDID - DEVICE: Earlens Processor (00850013007462)

GUDID

Device Identifier (DI) Information

Brand Name: Earlens Processor
Version or Model: IPR02XX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: IPR02XX
Company Name: EARLENS CORPORATION

Primary DI Number: 00850013007462
Issuing Agency: GS1
Commercial Distribution End Date: March 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 611658795 *Terms of Use

Device Description: Inductive Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black

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:	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?
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

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6f608c58-6202-4f5b-a947-b4142dd89dc2
Public Version Date: March 14, 2023
Public Version Number: 2
DI Record Publish Date: June 18, 2021