GRACE PISTON

GUDID 00844505000949

GRACE PISTON 0.4MM DIA X 6.00MM L PLATINUM RIBBON/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505000949
NIH Device Record Keyea60ffd1-568d-4ad7-b5fd-30234b2566ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameGRACE PISTON
Version Model Number412-600
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
GS100844505000949 [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 Date2020-03-18
Device Publish Date2016-02-18

On-Brand Devices [GRACE PISTON]

00844505006392GRACE PISTON 0.6MM DIA X 5.00MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006385GRACE PISTON 0.6MM DIA X 4.75MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006378GRACE PISTON 0.6MM DIA X 4.50MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006361GRACE PISTON 0.6MM DIA X 4.25MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006354GRACE PISTON 0.6MM DIA X 4.00MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006347GRACE PISTON 0.6MM DIA X 3.75MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006316GRACE PISTON 0.5MM DIA X 5.00MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006309GRACE PISTON 0.5MM DIA X 4.75MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006293GRACE PISTON 0.5MM DIA X 4.50MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006286GRACE PISTON 0.5MM DIA X 4.25MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006279GRACE PISTON 0.5MM DIA X 4.00MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006262GRACE PISTON 0.5MM DIA X 3.75MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505006194GRACE PISTON 0.4MM DIA X 5.00MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505000949GRACE PISTON 0.4MM DIA X 6.00MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505000932GRACE PISTON 0.4MM DIA X 4.75MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505000925GRACE PISTON 0.4MM DIA X 4.50MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505000918GRACE PISTON 0.4MM DIA X 4.25MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505000901GRACE PISTON 0.4MM DIA X 4.00MM L PLATINUM RIBBON/FLUOROPLASTIC
00844505000895GRACE PISTON 0.4MM DIA X 3.75MM L PLATINUM RIBBON/FLUOROPLASTIC

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