HA LITE ALTO TOTAL W/INTEGRATED SHOE

GUDID 00844505007573

HA LITE ALTO TOTAL W/INTEGRATED SHOE SIZERS INCLUDED HA/TITANIUM/SILICONE

Grace Medical, Inc.

Ossicular prosthesis, total
Primary Device ID00844505007573
NIH Device Record Key383730b6-a082-406d-aaca-1795b56659bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameHA LITE ALTO TOTAL W/INTEGRATED SHOE
Version Model Number630B
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
GS100844505007573 [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 LITE ALTO TOTAL W/INTEGRATED SHOE]

00844505007573HA LITE ALTO TOTAL W/INTEGRATED SHOE SIZERS INCLUDED HA/TITANIUM/SILICONE
00844505013550HA LITE ALTO TOTAL W/INTEGRATED SHOE SIZERS INCLUDED HA/TITANIUM/SILICONE

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