NiTiBOND Nitinol/Titanium 1007154

GUDID EHKM10071541

Ossicular Prosthesis, partial

Heinz Kurz GmbH

Ossicular prosthesis, partial
Primary Device IDEHKM10071541
NIH Device Record Key7bd8d9cf-8d34-4544-8897-906a8a2be8bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameNiTiBOND Nitinol/Titanium
Version Model Number1007154
Catalog Number1007154
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
HIBCCEHKM10071541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETBProsthesis, Partial Ossicular Replacement

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

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EHKM10071571Ossicular Prosthesis, partial
EHKM10071561Ossicular Prosthesis, partial
EHKM10071551Ossicular Prosthesis, partial
EHKM10071541Ossicular Prosthesis, partial
EHKM10071531Ossicular Prosthesis, partial
EHKM10071111Ossicular Prosthesis, partial
EHKM10071091Ossicular Prosthesis, partial
EHKM10071081Ossicular Prosthesis, partial
EHKM10071071Ossicular Prosthesis, partial
EHKM10071061Ossicular Prosthesis, partial
EHKM10071051Ossicular Prosthesis, partial
EHKM10071041Ossicular Prosthesis, partial
EHKM10071031Ossicular Prosthesis, partial

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