ECLIPSE MALLEUS PISTON MODIFIED LOOP

GUDID 00844505011136

ECLIPSE MALLEUS PISTON MODIFIED LOOP 0.6MM DIA X 8.00MM L NITINOL/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505011136
NIH Device Record Key8369b0e1-75c9-4c4b-aa06-d7250f4fe77b
Commercial Distribution StatusIn Commercial Distribution
Brand NameECLIPSE MALLEUS PISTON MODIFIED LOOP
Version Model Number443-800
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

Phone866-472-2363
Emailinfo@gracemedical.com
Phone866-472-2363
Emailinfo@gracemedical.com
Phone866-472-2363
Emailinfo@gracemedical.com
Phone866-472-2363
Emailinfo@gracemedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505011136 [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 Date2017-01-19

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