FLUOROPLASTIC PISTON

GUDID 00844505000475

FLUOROPLASTIC PISTON 0.3MM DIA X 5.00MM L

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505000475
NIH Device Record Keyfa146c91-d064-48ae-880d-c4d66a7620f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLUOROPLASTIC PISTON
Version Model Number400-500
Company DUNS030849173
Company NameGrace Medical, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100844505000475 [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 Date2020-03-13
Device Publish Date2016-02-18

On-Brand Devices [FLUOROPLASTIC PISTON]

00844505009720GRACE FLUOROPLASTIC PISTON W/O SLIT 0.4MM DIA. X 6.00MM L, 0.8MM ID FLUOROPLASTIC
00844505009638GRACE FLUOROPLASTIC PISTON 0.4MM DIA. X 6.00MM L, 0.8MM ID FLUOROPLASTIC
00844505008167FLUOROPLASTIC PISTON 0.6MM DIA X 8.00MM L
00844505000482FLUOROPLASTIC PISTON 0.3MM DIA X 6.00MM L
00844505000475FLUOROPLASTIC PISTON 0.3MM DIA X 5.00MM L
00844505000468FLUOROPLASTIC PISTON 0.3MM DIA X 4.50MM L

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