GRACE MEDICAL FLUOROPLASTIC PISTON

GUDID 00844505000741

FLUOROPLASTIC PISTON 0.5MM DIA X 5.00MM L

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
Primary Device ID00844505000741
NIH Device Record Keyd6596d03-60e5-4a8d-8f18-e18d4573335a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGRACE MEDICAL FLUOROPLASTIC PISTON
Version Model Number408-500
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
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
GS100844505000741 [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 [GRACE MEDICAL FLUOROPLASTIC PISTON]

00844505000758FLUOROPLASTIC PISTON 0.5MM DIA X 6.00MM L
00844505000741FLUOROPLASTIC PISTON 0.5MM DIA X 5.00MM L
00844505000734FLUOROPLASTIC PISTON 0.5MM DIA X 4.50MM L
00844505000727FLUOROPLASTIC PISTON ARRIGG SLIT MOD 0.4MM DIA x 6.00MM L
00844505000710FLUOROPLASTIC PISTON ARRIGG SLIT MOD 0.4MM DIA x 4.50MM L
00844505000703FLUOROPLASTIC PISTON ARRIGG SLIT MOD 0.4MM DIA x 4.25MM L
00844505000635FLUOROPLASTIC PISTON 0.8MM DIA X 6.00MM L
00844505000628FLUOROPLASTIC PISTON 0.8MM DIA X 5.00MM L
00844505000611FLUOROPLASTIC PISTON 0.8MM DIA X 4.50MM L
00844505000604FLUOROPLASTIC PISTON 0.8MM DIA X 4.00MM L
00844505000598FLUOROPLASTIC PISTON 0.8MM DIA X 3.50MM L
00844505000581FLUOROPLASTIC PISTON 0.6MM DIA X 6.00MM L
00844505000574FLUOROPLASTIC PISTON 0.6MM DIA X 5.00MM L
00844505000567FLUOROPLASTIC PISTON 0.6MM DIA X 4.50MM L
00844505000550FLUOROPLASTIC PISTON 0.6MM DIA X 4.00MM L
00844505000543FLUOROPLASTIC PISTON 0.6MM DIA X 3.50MM L
00844505000536FLUOROPLASTIC PISTON 0.4MM DIA X 6.00MM L
00844505000529FLUOROPLASTIC PISTON 0.4MM DIA X 5.00MM L
00844505000512FLUOROPLASTIC PISTON 0.4MM DIA X 4.50MM L
00844505000505FLUOROPLASTIC PISTON 0.4MM DIA X 4.00MM L
00844505000499FLUOROPLASTIC PISTON 0.4MM DIA X 3.50MM L
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.