CENTERED ALTO PARTIAL 10MM L

GUDID 00844505011563

CENTERED ALTO PARTIAL 10MM LENGTH TITANIUM/SILICONE

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505011563
NIH Device Record Key966e07ae-e08e-4fa9-944c-6caff195db88
Commercial Distribution StatusIn Commercial Distribution
Brand NameCENTERED ALTO PARTIAL 10MM L
Version Model Number655-M2
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505011563 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-10-16

On-Brand Devices [CENTERED ALTO PARTIAL 10MM L]

00844505011563CENTERED ALTO PARTIAL 10MM LENGTH TITANIUM/SILICONE
00844505013215CENTERED ALTO PARTIAL 10MM SIZERS INCLUDED LENGTH TITANIUM/SILICONE

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