DORNHOFFER FOOTPLATE SHOE

GUDID 00844505002219

DORNHOFFER FOOTPLATE SHOE 0.8MM DIA TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505002219
NIH Device Record Key9cb1703b-c341-4612-832f-b4abd3d05938
Commercial Distribution StatusIn Commercial Distribution
Brand NameDORNHOFFER FOOTPLATE SHOE
Version Model Number636-080
Company DUNS030849173
Company NameGrace Medical, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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+1(866)472-2363
Emailinfo@gracemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505002219 [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 Date2016-02-18

On-Brand Devices [DORNHOFFER FOOTPLATE SHOE]

00844505002226DORNHOFFER FOOTPLATE SHOE 0.9MM DIA TITANIUM
00844505002219DORNHOFFER FOOTPLATE SHOE 0.8MM DIA TITANIUM

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