GANTZ ALTO TOTAL

GUDID 00844505012300

GANTZ ALTO TOTAL SIZERS INCLUDED TITANIUM/SILICONE

Grace Medical, Inc.

Ossicular prosthesis, total
Primary Device ID00844505012300
NIH Device Record Key5b429673-9dd8-44ab-b0ad-5486174f89ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameGANTZ ALTO TOTAL
Version Model Number611B
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
GS100844505012300 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-16
Device Publish Date2019-08-08

On-Brand Devices [GANTZ ALTO TOTAL]

00844505012300GANTZ ALTO TOTAL SIZERS INCLUDED TITANIUM/SILICONE
00844505012799GANTZ ALTO TOTAL SIZERS INCLUDED TITANIUM/SILICONE

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