PRECISE HA LITE PARTIAL

GUDID 00844505013901

PRECISE HA LITE PARTIAL 1.50MM LENGTH HA/TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial
Primary Device ID00844505013901
NIH Device Record Key8c1b6d7c-b2b6-4bdc-b659-e50dfced52e0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRECISE HA LITE PARTIAL
Version Model Number770-150
Company DUNS030849173
Company NameGrace Medical, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505013901 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-21
Device Publish Date2022-03-11

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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