AccessGUDID - DEVICE: Earlens ELF USB (00850013007042)

GUDID

Device Identifier (DI) Information

Brand Name: Earlens ELF USB
Version or Model: ELF001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ELF001
Company Name: EARLENS CORPORATION

Primary DI Number: 00850013007042
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: Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).

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):	No
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?
60211	Audiometric/hearing device software	A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7274bf17-318c-4ede-a0e5-52af050bf458
Public Version Date: November 03, 2023
Public Version Number: 10
DI Record Publish Date: September 24, 2016