HA TOTAL PROSTHESIS

GUDID 00844505000109

HA TOTAL PROSTHESIS 4MM NOTCHED HEAD 0.8MM DIA. X 4MM LENGTH

Grace Medical, Inc.

Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total
Primary Device ID00844505000109
NIH Device Record Keyd4c08a0a-fd15-4539-a0c7-962a02c8b0fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameHA TOTAL PROSTHESIS
Version Model Number109
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505000109 [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 Date2016-02-18

On-Brand Devices [HA TOTAL PROSTHESIS]

00844505000123HA TOTAL PROSTHESIS 4MM NOTCHED HEAD 0.8MM DIA. X 8MM LENGTH
00844505000116HA TOTAL PROSTHESIS 4MM NOTCHED HEAD 0.8MM DIA. X 6MM LENGTH
00844505000109HA TOTAL PROSTHESIS 4MM NOTCHED HEAD 0.8MM DIA. X 4MM LENGTH
00844505000093HA TOTAL PROSTHESIS 4MM OFFSET HEAD 0.8MM DIA. X 8MM LENGTH
00844505000086HA TOTAL PROSTHESIS 4MM OFFSET HEAD 0.8MM DIA. X 6MM LENGTH
00844505000079HA TOTAL PROSTHESIS 4MM OFFSET HEAD 0.8MM DIA. X 4MM LENGTH
00844505000062HA TOTAL PROSTHESIS 4MM CENTERED HEAD 0.8MM DIA. X 8MM LENGTH
00844505000055HA TOTAL PROSTHESIS 4MM CENTERED HEAD 0.8MM DIA. X 6MM LENGTH
00844505000048HA TOTAL PROSTHESIS 4MM CENTERED HEAD 0.8MM DIA. X 4MM LENGTH
00844505000031HA TOTAL PROSTHESIS 3MM CENTERED HEAD 0.8MM DIA. X 8MM LENGTH
00844505000024HA TOTAL PROSTHESIS 3MM CENTERED HEAD 0.8MM DIA. X 6MM LENGTH
00844505000017HA TOTAL PROSTHESIS 3MM CENTERED HEAD 0.8MM DIA. X 4MM LENGTH
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