DORNHOFFER PARTIAL W/WINDOWS 2MM FIXED LEGTH

GUDID 00844505002363

DORNHOFFER PARTIAL W/WINDOWS 2MM FIXED LENGTH HA/TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505002363
NIH Device Record Key1a5a8d15-df9c-446a-9c36-b9c8cfb7cf17
Commercial Distribution StatusIn Commercial Distribution
Brand NameDORNHOFFER PARTIAL W/WINDOWS 2MM FIXED LEGTH
Version Model Number691
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
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505002363 [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

Devices Manufactured by Grace Medical, Inc.

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00844505014717 - SKULL BASE2025-10-06 DOUBLE-ENDED DISSECTOR STRAIGHT CUEVA AND SPOON STAINLESS STEEL
00844505014724 - SKULL BASE2025-10-06 EXTENDED THOMASSIN DISSECTOR DOUBLE-ENDED STAINLESS STEEL
00844505014502 - TITANIUM PISTON2025-09-26 TITANIUM PISTON 0.6MM DIA X 5.75MM L TITANIUM/RIBBON
00844505014687 - GRACE MEDICAL FLUOROPLASTIC PISTON2025-09-26 FLUOROPLASTIC PISTON 0.6MM DIA X 5.50MM L
00844505014489 - ECLIPSE PISTON2025-08-13 ECLIPSE PISTON 0.5MM DIA X 3.50MM L NITINOL/FLUOROPLASTIC
00844505014519 - TITANIUM PISTON2025-08-13 TITANIUM PISTON 0.4MM DIA X 5.75MM L TITANIUM/RIBBON

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