ECLIPSE FLAT RIBBON PISTON

GUDID 00844505009379

ECLIPSE FLAT RIBBON PISTON 0.6MM DIA X 4.75MM L NITINOL/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505009379
NIH Device Record Keycb4a4597-3147-4f29-89ea-6bd955b54eb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameECLIPSE FLAT RIBBON PISTON
Version Model Number472-475
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
GS100844505009379 [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 FLAT RIBBON PISTON]

00844505010481ECLIPSE FLAT RIBBON PISTON 0.5MM DIA X 5.00MM L NITINOL/FLUOROPLASTIC
00844505010474ECLIPSE FLAT RIBBON PISTON 0.5MM DIA X 4.75MM L NITINOL/FLUOROPLASTIC
00844505010467ECLIPSE FLAT RIBBON PISTON 0.5MM DIA X 4.50MM L NITINOL/FLUOROPLASTIC
00844505010450ECLIPSE FLAT RIBBON PISTON 0.5MM DIA X 4.25MM L NITINOL/FLUOROPLASTIC
00844505010443ECLIPSE FLAT RIBBON PISTON 0.5MM DIA X 4.00MM L NITINOL/FLUOROPLASTIC
00844505009386ECLIPSE FLAT RIBBON PISTON 0.6MM DIA X 5.00MM L NITINOL/FLUOROPLASTIC
00844505009379ECLIPSE FLAT RIBBON PISTON 0.6MM DIA X 4.75MM L NITINOL/FLUOROPLASTIC
00844505009362ECLIPSE FLAT RIBBON PISTON 0.6MM DIA X 4.50MM L NITINOL FLUOROPLASTIC
00844505009355ECLIPSE FLAT RIBBON PISTON 0.6MM DIA X 4.25MM L NITINOL.FLUOROPLASTIC
00844505009348ECLIPSE FLAT RIBBON PISTON 0.6MM DIA X 4.00MM L NITINOL/FLUOROPLASTIC

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