PRECISE OFFSET TOTAL

GUDID 00844505005739

PRECISE OFFSET TOTAL 7.00MM LENGTH TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, total
Primary Device ID00844505005739
NIH Device Record Key91d2a7f3-e876-4b18-9136-783ff655628e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRECISE OFFSET TOTAL
Version Model Number700-700
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
GS100844505005739 [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 Number4
Public Version Date2020-03-30
Device Publish Date2016-02-18

On-Brand Devices [PRECISE OFFSET TOTAL]

00844505005739PRECISE OFFSET TOTAL 7.00MM LENGTH TITANIUM
00844505005722PRECISE OFFSET TOTAL 6.75MM LENGTH TITANIUM
00844505005715PRECISE OFFSET TOTAL 6.50MM LENGTH TITANIUM
00844505005708PRECISE OFFSET TOTAL 6.25MM LENGTH TITANIUM
00844505005692PRECISE OFFSET TOTAL 6.00MM LENGTH TITANIUM
00844505005685PRECISE OFFSET TOTAL 5.75MM LENGTH TITANIUM
00844505005678PRECISE OFFSET TOTAL 5.50MM LENGTH TITANIUM
00844505005661PRECISE OFFSET TOTAL 5.25MM LENGTH TITANIUM
00844505005654PRECISE OFFSET TOTAL 5.00MM LENGTH TITANIUM
00844505005647PRECISE OFFSET TOTAL 4.75MM LENGTH TITANIUM
00844505005630PRECISE OFFSET TOTAL 4.50MM LENGTH TITANIUM
00844505005623PRECISE OFFSET TOTAL 4.25MM LENGTH TITANIUM
00844505005616PRECISE OFFSET TOTAL 4.00MM LENGTH TITANIUM
00844505005609PRECISE OFFSET TOTAL 3.75MM LENGTH TITANIUM
00844505005593PRECISE OFFSET TOTAL 3.50MM LENGTH TITANIUM
00844505005586PRECISE OFFSET TOTAL 3.25MM LENGTH TITANIUM
00844505005579PRECISE OFFSET TOTAL 3MM LENGTH TITANIUM

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