SUPER E PISTON

GUDID 00844505001908

SUPER E PISTON 0.6MM DIA X 5.00MM L NITINOL/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505001908
NIH Device Record Key0af71748-2bc5-4449-8ca1-13e98dccd587
Commercial Distribution StatusIn Commercial Distribution
Brand NameSUPER E PISTON
Version Model Number466-500
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
GS100844505001908 [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 Date2020-05-11
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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