HA ALTO TOTAL

GUDID 00844505002141

HA ALTO TOTAL SIZERS INCLUDED HA/TITANIUM/SILICONE

Grace Medical, Inc.

Ossicular prosthesis, total
Primary Device ID00844505002141
NIH Device Record Key745fb085-a3be-458f-88ff-ffd453ccf85c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHA ALTO TOTAL
Version Model Number620
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
GS100844505002141 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-02-18

On-Brand Devices [HA ALTO TOTAL]

00844505002141HA ALTO TOTAL SIZERS INCLUDED HA/TITANIUM/SILICONE
00844505012898HA ALTO TOTAL SIZERS INCLUDED HA/TITANIUM/SILICONE

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