Regensburg Type Total Titanium 1004458

GUDID EHKM10044581

Ossicular Prosthesis, total

Heinz Kurz GmbH

Ossicular prosthesis, total
Primary Device IDEHKM10044581
NIH Device Record Keyfd15618c-1a97-42c5-b4d3-40c115083b3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegensburg Type Total Titanium
Version Model Number1004458
Catalog Number1004458
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
HIBCCEHKM10044581 [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

On-Brand Devices [Regensburg Type Total Titanium]

EHKM10044621Ossicular Prosthesis, total
EHKM10044611Ossicular Prosthesis, total
EHKM10044601Ossicular Prosthesis, total
EHKM10044591Ossicular Prosthesis, total
EHKM10044581Ossicular Prosthesis, total

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