PRECISE HA LITE TOTAL

GUDID 00844505005036

PRECISE HA LITE TOTAL 4.00MM LENGTH HA/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
Primary Device ID00844505005036
NIH Device Record Key26fdfabd-e764-4085-9435-0ef6725ab9c1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRECISE HA LITE TOTAL
Version Model Number720-400
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
GS100844505005036 [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 TOTAL]

00844505009195PRECISE HA LITE TOTAL 3.75MM LENGTH HA/TITANIUM
00844505009188PRECISE HA LITE TOTAL 3.50MM LENGTH HA/TITANIUM
00844505009171PRECISE HA LITE TOTAL 3.25MM LENGTH HA/TITANIUM
00844505009164PRECISE HA LITE TOTAL 3.00MM LENGTH HA/TITANIUM
00844505005159PRECISE HA LITE TOTAL 7.00MM LENGTH HA/TITANIUM
00844505005142PRECISE HA LITE TOTAL 6.75MM LENGTH HA/TITANIUM
00844505005135PRECISE HA LITE TOTAL 6.50MM LENGTH HA/TITANIUM
00844505005128PRECISE HA LITE TOTAL 6.25MM LENGTH HA/TITANIUM
00844505005111PRECISE HA LITE TOTAL 6.00MM LENGTH HA/TITANIUM
00844505005104PRECISE HA LITE TOTAL 5.75MM LENGTH HA/TITANIUM
00844505005098PRECISE HA LITE TOTAL 5.50MM LENGTH HA/TITANIUM
00844505005081PRECISE HA LITE TOTAL 5.25MM LENGTH HA/TITANIUM
00844505005074PRECISE HA LITE TOTAL 5.00MM LENGTH HA/TITANIUM
00844505005067PRECISE HA LITE TOTAL 4.75MM LENGTH HA/TITANIUM
00844505005050PRECISE HA LITE TOTAL 4.50MM LENGTH HA/TITANIUM
00844505005043PRECISE HA LITE TOTAL 4.25MM LENGTH HA/TITANIUM
00844505005036PRECISE HA LITE TOTAL 4.00MM LENGTH HA/TITANIUM
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