PRECISE HA LITE PARTIAL

GUDID 00844505005289

PRECISE CENTERED TOTAL 3.00MM LENGTH TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, total
Primary Device ID00844505005289
NIH Device Record Key7182de9a-1def-4424-ad81-a1ba3adee17b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRECISE HA LITE PARTIAL
Version Model Number705-300
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
GS100844505005289 [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 HA LITE PARTIAL]

00844505005289PRECISE CENTERED TOTAL 3.00MM LENGTH TITANIUM
00844505005272PRECISE HA LITE PARTIAL 4.50MM LENGTH HA/TITANIUM
00844505005265PRECISE HA LITE PARTIAL 4.25MM LENGTH HA/TITANIUM
00844505005258PRECISE HA LITE PARTIAL 4.00MM LENGTH HA/TITANIUM
00844505005241PRECISE HA LITE PARTIAL 3.75MM LENGTH HA/TITANIUM
00844505005234PRECISE HA LITE PARTIAL 3.50MM LENGTH HA/TITANIUM
00844505005227PRECISE HA LITE PARTIAL 3.25MM LENGTH HA/TITANIUM
00844505005210PRECISE HA LITE PARTIAL 3.00MM LENGTH HA/TITANIUM
00844505005203PRECISE HA LITE PARTIAL 2.75MM LENGTH HA/TITANIUM
00844505005197PRECISE HA LITE PARTIAL 2.50MM LENGTH HA/TITANIUM
00844505005180PRECISE HA LITE PARTIAL 2.25MM LENGTH HA/TITANIUM
00844505005173PRECISE HA LITE PARTIAL 2.00MM LENGTH HA/TITANIUM
00844505005166PRECISE HA LITE PARTIAL 1.75MM LENGTH HA/TITANIUM
00844505013901PRECISE HA LITE PARTIAL 1.50MM LENGTH HA/TITANIUM

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