TeliTalk™ Electrolarynx

GUDID 00813124010875

GRIFFIN LABORATORIES

Transcervical artificial larynx
Primary Device ID00813124010875
NIH Device Record Key4fc959d1-351d-4413-95fc-e7d7355167b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeliTalk™ Electrolarynx
Version Model NumberK5200LL-FTRI
Company DUNS016865375
Company NameGRIFFIN LABORATORIES
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS100813124010875 [Primary]

FDA Product Code

ESELarynx, Artificial (Battery-Powered)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17

On-Brand Devices [TeliTalk™ Electrolarynx]

00813124010349K5200LL
00813124010332K5200BT
00813124010875K5200LL-FTRI
00813124010868K5200BT-FTRI

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