ECLIPSE PISTON

GUDID 00844505001939

ECLIPSE PISTON 0.5MM DIA X 4.25MM L NITINOL/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505001939
NIH Device Record Keyed7e794e-caed-4457-a925-c8d25e36b844
Commercial Distribution StatusIn Commercial Distribution
Brand NameECLIPSE PISTON
Version Model Number467-425
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
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505001939 [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 PISTON]

00844505010184ECLIPSE PISTON 0.5MM DIA X 5.50MM L NITINOL/FLUOROPLASTIC
00844505008617ECLIPSE PISTON 0.6MM DIA X 5.25MM L NITINOL/FLUOROPLASTIC
00844505008563ECLIPSE PISTON 0.4MM DIA X 6.00MM L NITINOL/FLUOROPLASTIC
00844505006767ECLIPSE PISTON 0.6mm DIA X 4.75mm L NITINOL/TITANIUM
00844505006750ECLIPSE PISTON 0.6mm DIA X 4.50mm L NITINOL/TITANIUM
00844505006743ECLIPSE PISTON 0.6mm DIA X 4.25mm L NITINOL/TITANIUM
00844505006736ECLIPSE PISTON 0.6mm DIA X 4.00mm L NITINOL/TITANIUM
00844505006729ECLIPSE PISTON 0.6mm DIA X 3.75mm L NITINOL/TITANIUM
00844505002042ECLIPSE PISTON 0.6MM DIA X 6.00MM L NITINOL/FLUOROPLASTIC
00844505002035ECLIPSE PISTON 0.6MM DIA X 5.00MM L NITINOL/FLUOROPLASTIC
00844505002028ECLIPSE PISTON 0.6MM DIA X 4.75MM L NITINOL/FLUOROPLASTIC
00844505002011ECLIPSE PISTON 0.6MM DIA X 4.50MM L NITINOL/FLUOROPLASTIC
00844505002004ECLIPSE PISTON 0.6MM DIA X 4.25MM L NITINOL/FLUOROPLASTIC
00844505001991ECLIPSE PISTON 0.6MM DIA X 4.00MM L NITINOL/FLUOROPLASTIC
00844505001984ECLIPSE PISTON 0.6MM DIA X 3.75MM L NITINOL/FLUOROPLASTIC
00844505001977ECLIPSE PISTON 0.5MM DIA X 6.00MM L NITINOL/FLUOROPLASTIC
00844505001960ECLIPSE PISTON 0.5MM DIA X 5.00MM L NITINOL/FLUOROPLASTIC
00844505001953ECLIPSE PISTON 0.5MM DIA X 4.75MM L NITINOL/FLUOROPLASTIC
00844505001946ECLIPSE PISTON 0.5MM DIA X 4.50MM L NITINOL/FLUOROPLASTIC
00844505001939ECLIPSE PISTON 0.5MM DIA X 4.25MM L NITINOL/FLUOROPLASTIC
00844505001922ECLIPSE PISTON 0.5MM DIA X 4.00MM L NITINOL/FLUOROPLASTIC
00844505001915ECLIPSE PISTON 0.5MM DIA X 3.75MM L NITINOL/FLUOROPLASTIC
00844505013895ECLIPSE PISTON 0.4MM DIA X 8.00MM L NITINOL/FLUOROPLASTIC
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