Earlens Tympanic Lens

GUDID 08500130070246

Inductive Tympanic Lens L- left, R - Right

EARLENS CORPORATION

Tympanic membrane contact hearing aid tympanic transducer
Primary Device ID08500130070246
NIH Device Record Key9e35c62e-ace2-4607-a281-ef2dfde26e01
Commercial Distribution StatusIn Commercial Distribution
Brand NameEarlens Tympanic Lens
Version Model NumberITL01X
Company DUNS611658795
Company NameEARLENS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108500130070246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLKTympanic Membrane Direct Contact Hearing Aid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-14
Device Publish Date2019-05-06

On-Brand Devices [Earlens Tympanic Lens]

08500130070253Inductive Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this
08500130070246Inductive Tympanic Lens L- left, R - Right
00850013007257Inductive Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this
00850013007240Inductive Tympanic Lens L- left, R - Right
00850013007103Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this product bo
00850013007097Tympanic Lens L- left, R - Right

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