ECLIPSE DE LA CRUZ PISTON

GUDID 00844505005968

ECLIPSE PISTON DE LA CRUZ 0.6MM DIA X 4.75MM L NITINOL/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505005968
NIH Device Record Keyd04274c8-db66-45f8-8bab-1309b8de15a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameECLIPSE DE LA CRUZ PISTON
Version Model Number469-475
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505005968 [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 [ECLIPSE DE LA CRUZ PISTON]

00844505005968ECLIPSE PISTON DE LA CRUZ 0.6MM DIA X 4.75MM L NITINOL/FLUOROPLASTIC
00844505005951ECLIPSE PISTON DE LA CRUZ 0.6MM DIA X 4.50MM L NITINOL/FLUOROPLASTIC
00844505005944ECLIPSE PISTON DE LA CRUZ 0.6MM DIA X 4.25MM L NITINOL/FLUOROPLASTIC
00844505005937ECLIPSE PISTON DE LA CRUZ 0.6MM DIA X 4.00MM L NITINOL/FLUOROPLASTIC

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