Right Femur - Left Tibia Arm Assembly 50-0014

GUDID 00850046497193

For Use with 80-0006.

POLARISAR, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00850046497193
NIH Device Record Keye82da0d2-7413-4f30-b34d-29b3af72a7c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameRight Femur - Left Tibia Arm Assembly
Version Model Number50-0014
Catalog Number50-0014
Company DUNS035071717
Company NamePOLARISAR, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com
Phone800-903-6894
Emailcustomerservice@thinkpolaris.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850046497193 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-24
Device Publish Date2025-06-16

Devices Manufactured by POLARISAR, INC.

00850046497179 - STELLAR Knee Marker Kit2025-06-24 For use with TruFix Pin Kit (80-0005)
00850046497186 - TruFix Pin Kit2025-06-24 TruFix Pin Kit for use with 80-0006 STELLAR Knee Marker Kit
00850046497193 - Right Femur - Left Tibia Arm Assembly2025-06-24For Use with 80-0006.
00850046497193 - Right Femur - Left Tibia Arm Assembly2025-06-24 For Use with 80-0006.
00850046497209 - Left Femur - Right Tibia Arm Assembly2025-06-24 For Use with 80-0006.
00850046497001 - STELLAR Knee2025-03-11 Kit, Total Knee, Left
00850046497018 - STELLAR Knee2025-03-11 Kit, Total Knee, Right
00850046497025 - STELLAR Knee2025-03-11 STELLAR Knee Reusable Instrumentation
00850046497032 - STELLAR Knee2025-03-11 Universal Resection Guide
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