ECLIPSE MALLEUS PISTON

GUDID 00844505006514

ECLIPSE MALLEUS PISTON 0.6MM DIA X 7.00MM L NITINOL/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505006514
NIH Device Record Key50124bb4-cb4e-4394-962a-7c062943e050
Commercial Distribution StatusIn Commercial Distribution
Brand NameECLIPSE MALLEUS PISTON
Version Model Number442-700
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
GS100844505006514 [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 MALLEUS PISTON]

00844505010238ECLIPSE MALLEUS PISTON 0.4MM DIA X 8.00MM L NITINOL/FLUOROPLASTIC
00844505010221ECLIPSE MALLEUS PISTON 0.4MM DIA X 7.00MM L NITINOL/FLUOROPLASTIC
00844505010214ECLIPSE MALLEUS PISTON 0.4MM DIA X 6.50MM L NITINOL/FLUOROPLASTIC
00844505010207ECLIPSE MALLEUS PISTON 0.4MM DIA X 6.00MM L NITINOL/FLUOROPLASTIC
00844505010191ECLIPSE MALLEUS PISTON 0.4MM DIA X 5.50MM L NITINOL/FLUOROPLASTIC
00844505006521ECLIPSE MALLEUS PISTON 0.6MM DIA X 8.00MM L NITINOL/FLUOROPLASTIC
00844505006514ECLIPSE MALLEUS PISTON 0.6MM DIA X 7.00MM L NITINOL/FLUOROPLASTIC
00844505006507ECLIPSE MALLEUS PISTON 0.6MM DIA X 6.50MM L NITINOL/FLUOROPLASTIC
00844505006491ECLIPSE MALLEUS PISTON 0.6MM DIA X 6.00MM L NITINOL/FLUOROPLASTIC
00844505006484ECLIPSE MALLEUS PISTON 0.6MM DIA X 5.50MM L NITINOL/FLUOROPLASTIC

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.