CENTERED ALTO PARTIAL

GUDID 00844505008150

CENTERED ALTO PARTIAL 7MM LENGTH TITANIUM/SILICONE

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505008150
NIH Device Record Key67a74a64-594c-417e-a0f1-c8511fe63914
Commercial Distribution StatusIn Commercial Distribution
Brand NameCENTERED ALTO PARTIAL
Version Model Number655-M1
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
GS100844505008150 [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 Date2020-03-18
Device Publish Date2016-02-18

On-Brand Devices [CENTERED ALTO PARTIAL]

00844505008150CENTERED ALTO PARTIAL 7MM LENGTH TITANIUM/SILICONE
00844505002288CENTERED ALTO PARTIAL SIZERS INCLUDED TITANIUM/SILICONE
00844505013390CENTERED ALTO PARTIAL SIZERS INCLUDED TITANIUM/SILICONE
00844505013680CENTERED ALTO PARTIAL 7MM LENGTH, SIZERS INCLUDED TITANIUM/SILICONE

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