PRECISE OFFSET PARTIAL

GUDID 00844505005784

PRECISE OFFSET PARTIAL 2.00MM LENGTH TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505005784
NIH Device Record Key5777ead8-06ed-4be7-a6bb-f4ece5aacc87
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRECISE OFFSET PARTIAL
Version Model Number750-200
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505005784 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-27
Device Publish Date2016-02-18

On-Brand Devices [PRECISE OFFSET PARTIAL]

00844505006927PRECISE OFFSET PARTIAL 1.50MM LENGTH TITANIUM
00844505006910PRECISE OFFSET PARTIAL 1.25MM LENGTH TITANIUM
00844505006903PRECISE OFFSET PARTIAL 1.00MM LENGTH TITANIUM
00844505006897PRECISE OFFSET PARTIAL 0.75MM LENGTH TITANIUM
00844505005883PRECISE OFFSET PARTIAL 4.50MM LENGTH TITANIUM
00844505005876PRECISE OFFSET PARTIAL 4.25MM LENGTH TITANIUM
00844505005869PRECISE OFFSET PARTIAL 4.00MM LENGTH TITANIUM
00844505005852PRECISE OFFSET PARTIAL 3.75MM LENGTH TITANIUM
00844505005845PRECISE OFFSET PARTIAL 3.50MM LENGTH TITANIUM
00844505005838PRECISE OFFSET PARTIAL 3.25MM LENGTH TITANIUM
00844505005821PRECISE OFFSET PARTIAL 3.00MM LENGTH TITANIUM
00844505005814PRECISE OFFSET PARTIAL 2.75MM LENGTH TITANIUM
00844505005807PRECISE OFFSET PARTIAL 2.50MM LENGTH TITANIUM
00844505005791PRECISE OFFSET PARTIAL 2.25MM LENGTH TITANIUM
00844505005784PRECISE OFFSET PARTIAL 2.00MM LENGTH TITANIUM
00844505005777PRECISE OFFSET PARTIAL 1.75MM LENGTH TITANIUM

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