HABERMAN ALTO PARTIAL RECTANGLE HEAD

GUDID 00844505006156

HABERMAN ALTO PARTIAL RECTANGLE HEAD SIZERS INCLUDED HA/TITANIUM/SILICONE

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505006156
NIH Device Record Keyd90edf21-127d-497c-814e-1e909ba7daae
Commercial Distribution StatusIn Commercial Distribution
Brand NameHABERMAN ALTO PARTIAL RECTANGLE HEAD
Version Model Number658
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
GS100844505006156 [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 Date2016-02-18

On-Brand Devices [HABERMAN ALTO PARTIAL RECTANGLE HEAD]

00844505006156HABERMAN ALTO PARTIAL RECTANGLE HEAD SIZERS INCLUDED HA/TITANIUM/SILICONE
00844505012843HABERMAN ALTO PARTIAL RECT. HEAD SIZERS INCLUDED HA/TITANIUM/SILICONE

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