SATALOFF MALLEUS PISTON

GUDID 00844505006231

SATALOFF MALLEUS PISTON 0.6MM DIA X 5.75MM L TITANIUM/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505006231
NIH Device Record Key989923a2-93e4-470a-a435-56ae6f31a090
Commercial Distribution StatusIn Commercial Distribution
Brand NameSATALOFF MALLEUS PISTON
Version Model Number417-575
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
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505006231 [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 [SATALOFF MALLEUS PISTON]

00844505006255SATALOFF MALLEUS PISTON 0.6MM DIA X 6.25MM L TITANIUM/FLUOROPLASTIC
00844505006248SATALOFF MALLEUS PISTON 0.6MM DIA X 6.00MM L TITANIUM/FLUOROPLASTIC
00844505006231SATALOFF MALLEUS PISTON 0.6MM DIA X 5.75MM L TITANIUM/FLUOROPLASTIC
00844505006224SATALOFF MALLEUS PISTON 0.6MM DIA X 5.50MM L TITANIUM/FLUOROPLASTIC
00844505006217SATALOFF MALLEUS PISTON 0.6MM DIA X 5.25MM L TITANIUM/FLUOROPLASTIC

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