Klassic ONE Stem Trial Caddy for PS-Max Stem + Augment Instrument Tray

GUDID 00810094691899

Stem Trial Caddy for PS-Max Stem + Augment Instrument Tray

TOTAL JOINT ORTHOPEDICS, INC.

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device ID00810094691899
NIH Device Record Keyc7cf0957-67eb-45a5-8cad-21a1a62f16ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameKlassic ONE Stem Trial Caddy for PS-Max Stem + Augment Instrument Tray
Version Model Number2414.00.100
Company DUNS078416717
Company NameTOTAL JOINT ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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

Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100810094691899 [Primary]

FDA Product Code

OJHOrthopedic Tray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


[00810094691899]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-11
Device Publish Date2024-06-03

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

00810094691646 - Posterior Femoral Augment Trial2024-06-11 Posterior Femoral Augment Trial Size 1-2, 5mm
00810094691653 - Posterior Femoral Augment Trial2024-06-11 Posterior Femoral Augment Trial Size 1-2, 10mm
00810094691660 - Posterior Femoral Augment Trial2024-06-11 Posterior Femoral Augment Trial Size 3-4, 5mm
00810094691677 - Posterior Femoral Augment Trial2024-06-11 Posterior Femoral Augment Trial Size 3-4, 10mm
00810094691684 - Posterior Femoral Augment Trial2024-06-11 Posterior Femoral Augment Trial Size 5-6-7, 5mm
00810094691691 - Posterior Femoral Augment Trial2024-06-11 Posterior Femoral Augment Trial Size 5-6-7, 10mm
00810094691707 - Distal Femoral Augment Trial2024-06-11 Distal Femoral Augment Trial Size 1-2, 5mm
00810094691714 - Distal Femoral Augment Trial2024-06-11 Distal Femoral Augment Trial Size 1-2, 10mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.