TTP-VARIAC System Total 1004020

GUDID EHKM10040201

Ossicular Prosthesis, total

Heinz Kurz GmbH

Ossicular prosthesis, total
Primary Device IDEHKM10040201
NIH Device Record Keyee915e33-a6ca-4c51-bfbe-fdf5edf0680a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTTP-VARIAC System Total
Version Model Number1004020
Catalog Number1004020
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
HIBCCEHKM10040201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETAReplacement, Ossicular Prosthesis, Total

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

Devices Manufactured by Heinz Kurz GmbH

EHKM10022601 - CliP Partial Prosthesis Titanium2023-10-09 Ossicular Prosthesis, partial
EHKM10022641 - CliP Partial Prosthesis Titanium2023-10-09 Ossicular Prosthesis, partial
EHKM10022661 - CliP Partial Prosthesis Titanium2023-10-09 Ossicular Prosthesis, partial
EHKM10022681 - CliP Partial Prosthesis Titanium2023-10-09 Ossicular Prosthesis, partial
EHKM10022701 - CliP Partial Prosthesis Titanium2023-10-09 Ossicular Prosthesis, partial
EHKM10022721 - CliP Partial Prosthesis Titanium2023-10-09 Ossicular Prosthesis, partial
EHKM10022731 - CliP Partial Prosthesis Titanium2023-10-09 Ossicular Prosthesis, partial
EHKM10022741 - CliP Partial Prosthesis Titanium2023-10-09 Ossicular Prosthesis, partial

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