AccessGUDID - DEVICE: Earlens Ear Tip (00850013007219)

GUDID

Device Identifier (DI) Information

Brand Name: Earlens Ear Tip
Version or Model: ET01X
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ET01X
Company Name: EARLENS CORPORATION

Primary DI Number: 00850013007219
Issuing Agency: GS1
Commercial Distribution End Date: June 09, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 611658795 *Terms of Use

Device Description: Inductive 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:	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?
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: 5683441e-1282-49e2-870b-74fc2ac17a30
Public Version Date: June 12, 2023
Public Version Number: 3
DI Record Publish Date: May 06, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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