Dispensing Tips (Blue) IDT01

GUDID 00850013007394

EARLENS CORPORATION

Dental material mixing nozzle, non-sterile
Primary Device ID00850013007394
NIH Device Record Keyd0e1468c-4e96-49ee-ba23-60f9a6fe75b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDispensing Tips (Blue)
Version Model NumberIDT01
Catalog NumberIDT01
Company DUNS611658795
Company NameEARLENS CORPORATION
Device Count3
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850013007394 [Primary]
GS100850013007431 [Unit of Use]

FDA Product Code

LDGKit, Earmold, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-30
Device Publish Date2021-06-22

Devices Manufactured by EARLENS CORPORATION

08500130070192 - Earlens ELF USB2023-11-03 Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot n
00850013007387 - Impression Dispenser2023-06-19
00850013007516 - Earlens Processor, Champagne 2023-06-19
00850013007523 - Earlens Processor, Silver2023-06-19
00850013007530 - Earlens Processor, Black2023-06-19
00850013007547 - Earlens Ear Tip, Left2023-06-19
00850013007554 - Earlens Ear Tip, Right2023-06-19
00850013007561 - Earlens Tympanic Lens, Left2023-06-19

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