TITANIUM PISTON

GUDID 00844505007085

TITANIUM PISTON 0.6MM DIA X 5.00MM L TITANIUM/RIBBON

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505007085
NIH Device Record Keyaeb5760d-d85d-4ec1-8ceb-429cdd483289
Commercial Distribution StatusIn Commercial Distribution
Brand NameTITANIUM PISTON
Version Model Number461-500
Company DUNS030849173
Company NameGrace Medical, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS100844505007085 [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 Number4
Public Version Date2020-05-04
Device Publish Date2016-02-18

On-Brand Devices [TITANIUM PISTON]

00844505007108TITANIUM PISTON 0.6MM DIA X 5.50MM L TITANIUM/RIBBON
00844505007092TITANIUM PISTON 0.6MM DIA X 5.25MM L TITANIUM/RIBBON
00844505007085TITANIUM PISTON 0.6MM DIA X 5.00MM L TITANIUM/RIBBON
00844505006880TITANIUM PISTON 0.4MM DIA X 5.50MM L TITANIUM/RIBBON
00844505006873TITANIUM PISTON 0.4MM DIA X 5.25MM L TITANIUM/RIBBON
00844505006866TITANIUM PISTON 0.4MM DIA X 5.00MM L TITANIUM/RIBBON
00844505006859TITANIUM PISTON 0.4MM DIA X 4.75MM L TITANIUM/RIBBON
00844505006842TITANIUM PISTON 0.4MM DIA X 4.50MM L TITANIUM/RIBBON
00844505006835TITANIUM PISTON 0.4MM DIA X 4.25MM L TITANIUM/RIBBON
00844505006828TITANIUM PISTON 0.4MM DIA X 4.00MM L TITANIUM/RIBBON
00844505006811TITANIUM PISTON 0.4MM DIA X 3.75MM L TITANIUM/RIBBON
00844505006804TITANIUM PISTON 0.4MM DIA X 3.50MM L TITANIUM/RIBBON
00844505006644TITANIUM PISTON 0.6MM DIA X 4.75MM L TITANIUM/RIBBON
00844505006637TITANIUM PISTON 0.6MM DIA X 4.50MM L TITANIUM/RIBBON
00844505006620TITANIUM PISTON 0.6MM DIA X 4.25MM L TITANIUM/RIBBON
00844505006613TITANIUM PISTON 0.6MM DIA X 4.00MM L TITANIUM/RIBBON
00844505006606TITANIUM PISTON 0.6MM DIA X 3.75MM L TITANIUM/RIBBON
00844505006590TITANIUM PISTON 0.6MM DIA X 3.50MM L TITANIUM/RIBBON
00844505001007TITANIUM PISTON 0.5MM DIA X 4.75MM L TITANIUM
00844505000987TITANIUM PISTON 0.5MM DIA X 4.50MM L TITANIUM/RIBBON
00844505000963TITANIUM PISTON 0.5MM DIA X 4.25MM L TITANIUM/RIBBON
00844505000956TITANIUM PISTON 0.5MM DIA X 4.00MM L TITANIUM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.