Titanium-Vocal-Fold-Medial-Implant 5001001

GUDID EHKM50010011

Preformed vocal cord medialization implant

Heinz Kurz GmbH

Preformed vocal cord medialization implant
Primary Device IDEHKM50010011
NIH Device Record Key6f55a23d-fc84-448d-b4da-3d396e2e73e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitanium-Vocal-Fold-Medial-Implant
Version Model Number5001001
Catalog Number5001001
Company DUNS341155720
Company NameHeinz Kurz GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49707291790
Emailinfo@kurzmed.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEHKM50010011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-21

On-Brand Devices [Titanium-Vocal-Fold-Medial-Implant ]

EHKM50010031Preformed vocal cord medialization implant
EHKM50010011Preformed vocal cord medialization implant
EHKM50010001Preformed vocal cord medialization implant

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