TITANIUM/FLUOROPLASTIC PISTON

GUDID 00844505000826

TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 5.00MM L

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505000826
NIH Device Record Keyae54d9a5-d79f-410f-853b-ea360585ad89
Commercial Distribution StatusIn Commercial Distribution
Brand NameTITANIUM/FLUOROPLASTIC PISTON
Version Model Number409-500
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
GS100844505000826 [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 [TITANIUM/FLUOROPLASTIC PISTON]

00844505000826TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 5.00MM L
00844505000819TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 4.75MM L
00844505000802TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 4.50MM L
00844505000796TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 4.25MM L
00844505000789TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 4.00MM L
00844505000772TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L

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