AccessGUDID - DEVICE: Earlens Wireless Programmer (00850013007110)

GUDID

Device Identifier (DI) Information

Brand Name: Earlens Wireless Programmer
Version or Model: WPUSB01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: WPUSB01
Company Name: EARLENS CORPORATION

Primary DI Number: 00850013007110
Issuing Agency: GS1
Commercial Distribution End Date: January 29, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 611658795 *Terms of Use

Device Description: Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number

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?
61462	Hearing aid/implant system programming interface unit	A portable, electrically-powered device intended to facilitate the wireless or wired connection of a hearing aid or implant system component (e.g., sound processor) to a computer for programming of the hearing device with patient-specific settings and sometimes assessment. It typically consists of a small unit attached to the hearing device. This is a reusable device.	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: 2c30b491-0a68-44ca-ac13-5674d6a0e816
Public Version Date: June 12, 2023
Public Version Number: 9
DI Record Publish Date: September 24, 2016