Calcaneal Plates CLSR-09

GUDID 00842188100215

CalcaneusSinusTarsiPlate, Rt, 9-Hole

TRIMED, INCORPORATED

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID00842188100215
NIH Device Record Keye1b632ce-4324-4ca0-ac4a-ae667f1dcaaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalcaneal Plates
Version Model NumberCLSR-09
Catalog NumberCLSR-09
Company DUNS138041277
Company NameTRIMED, INCORPORATED
Device Count1
DM Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100842188100215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


[00842188100215]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-07

On-Brand Devices [Calcaneal Plates]

00842188100239CalcaneusSinusTarsiPlate, Rt, 11-Hole
00842188100222CalcaneusSinusTarsiPlate, Lt, 11-Hole
00842188100215CalcaneusSinusTarsiPlate, Rt, 9-Hole
00842188100208CalcaneusSinusTarsiPlate, Lt, 9-Hole
00842188100192CalcaneusSinusTarsiPlate, Rt, 8-Hole
00842188100185CalcaneusSinusTarsiPlate, Lt, 8-Hole
00842188100178CalcaneusSinusTarsiPlate, Rt, 7-Hole
00842188100161CalcaneusSinusTarsiPlate, Lt, 7-Hole
00842188100154CalcaneusPerimeterPlate, Rt, 66mm
00842188100147CalcaneusPerimeterPlate, Lt, 66mm
00842188100130CalcaneusPerimeterPlate, Rt, 54mm
00842188100123CalcaneusPerimeterPlate, Lt, 54mm

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