Sanibel Supply

GUDID 05711117221848

Interacoustics A/S

Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion Earphone cushion
Primary Device ID05711117221848
NIH Device Record Keyc557d4d2-ef8e-4fa8-87d7-6d7ed92b9259
Commercial Distribution StatusIn Commercial Distribution
Brand NameSanibel Supply
Version Model NumberEARturtle
Company DUNS306308354
Company NameInteracoustics A/S
Device Count2
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105711117221848 [Primary]
GS105711117222081 [Package]
Package: Box [20 Units]
In Commercial Distribution
GS105711117226492 [Unit of Use]

FDA Product Code

ETTCushion, Earphone (For Audiometric Testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-27
Device Publish Date2021-10-19

On-Brand Devices [Sanibel Supply]

05711117221848EARturtle
05711117223101ADI eartip sample kit, E3
05711117221107ADI eartip sample kit, Oaktree
05711117208238ADI eartip sample kit

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