PARTIAL TILT TOP 3MM HEAD CENTERED

GUDID 00844505000321

PARTIAL TILT TOP 3MM HEAD CENTERED 1.12MM ID DIA X 6MM L HA/OTOSIL

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505000321
NIH Device Record Keyf6be0195-c704-4241-8c7a-c757ed08c0d3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePARTIAL TILT TOP 3MM HEAD CENTERED
Version Model Number250
Company DUNS030849173
Company NameGrace Medical, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505000321 [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 Number4
Public Version Date2020-03-23
Device Publish Date2016-02-18

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10844505014165 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 30 PACK
10844505014189 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 30 PACK

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