PRECISE CENTERED TOTAL

GUDID 00844505005302

PRECISE CENTERED TOTAL 3.50MM LENGTH TITANIUM

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 Ossicular prosthesis, total
Primary Device ID00844505005302
NIH Device Record Key70d25f2c-fc61-4b84-939b-a24d53549ec0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRECISE CENTERED TOTAL
Version Model Number705-350
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
GS100844505005302 [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 [PRECISE CENTERED TOTAL]

00844505005449PRECISE CENTERED TOTAL 7.00MM LENGTH TITANIUM
00844505005432PRECISE CENTERED TOTAL 6.75MM LENGTH TITANIUM
00844505005425PRECISE CENTERED TOTAL 6.50MM LENGTH TITANIUM
00844505005418PRECISE CENTERED TOTAL 6.25MM LENGTH TITANIUM
00844505005401PRECISE CENTERED TOTAL 6.00MM LENGTH TITANIUM
00844505005395PRECISE CENTERED TOTAL 5.75MM LENGTH TITANIUM
00844505005388PRECISE CENTERED TOTAL 5.50MM LENGTH TITANIUM
00844505005371PRECISE CENTERED TOTAL 5.25MM LENGTH TITANIUM
00844505005364PRECISE CENTERED TOTAL 5.00MM LENGTH TITANIUM
00844505005357PRECISE CENTERED TOTAL 4.75MM LENGTH TITANIUM
00844505005340PRECISE CENTERED TOTAL 4.50MM LENGTH TITANIUM
00844505005333PRECISE CENTERED TOTAL 4.25MM LENGTH TITANIUM
00844505005326PRECISE CENTERED TOTAL 4.00MM LENGTH TITANIUM
00844505005319PRECISE CENTERED TOTAL 3.75MM LENGTH TITANIUM
00844505005302PRECISE CENTERED TOTAL 3.50MM LENGTH TITANIUM
00844505005296PRECISE CENTERED TOTAL 3.25MM LENGTH TITANIUM
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