SUPER E PISTON

GUDID 00844505001885

SUPER E PISTON 0.6MM DIA X 4.50MM L NITINOL/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial
Primary Device ID00844505001885
NIH Device Record Keyaa406f01-fed7-493b-884a-db2659a7550a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSUPER E PISTON
Version Model Number466-450
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
Phone+1(866)472-2363
Emailinfo@gracemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505001885 [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 [SUPER E PISTON]

00844505001908SUPER E PISTON 0.6MM DIA X 5.00MM L NITINOL/FLUOROPLASTIC
00844505001892SUPER E PISTON 0.6MM DIA X 4.75MM L NITINOL/FLUOROPLASTIC
00844505001885SUPER E PISTON 0.6MM DIA X 4.50MM L NITINOL/FLUOROPLASTIC
00844505001878SUPER E PISTON 0.6MM DIA X 4.25MM L NITINOL/FLUOROPLASTIC
00844505001861SUPER E PISTON 0.6MM DIA X 4.00MM L NITINOL/FLUOROPLASTIC
00844505001854SUPER E PISTON 0.6MM DIA X 3.75MM L NITINOL/FLUOROPLASTIC
00844505001847SUPER E PISTON 0.5MM DIA X 5.00MM L NITINOL/FLUOROPLASTIC
00844505001830SUPER E PISTON 0.5MM DIA X 4.75MM L NITINOL/FLUOROPLASTIC
00844505001823SUPER E PISTON 0.5MM DIA X 4.50MM L NITINOL/FLUOROPLASTIC
00844505001816SUPER E PISTON 0.5MM DIA X 4.25MM L NITINOL/FLUOROPLASTIC
00844505001809SUPER E PISTON 0.5MM DIA X 4.00MM L NITINOL/FLUOROPLASTIC
00844505001793SUPER E PISTON 0.5MM DIA X 3.75MM L NITINOL/FLUOROPLASTIC
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