ECLIPSE MALLEUS PISTON

GUDID 00844505010221

ECLIPSE MALLEUS PISTON 0.4MM DIA X 7.00MM L NITINOL/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505010221
NIH Device Record Key8bb897b2-5e23-439f-85f0-0e2aeb745435
Commercial Distribution StatusIn Commercial Distribution
Brand NameECLIPSE MALLEUS PISTON
Version Model Number440-700
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 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505010221 [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 Date2017-11-21

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

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