Talon DistalFix A/R Femoral Nail Instrument Tray ODI-F100

GUDID B058ODIF1001

Talon DistalFix A/R Femoral Nail Instrument Tray

Orthopedic Designs North America, Inc.

Instrument tray, reusable
Primary Device IDB058ODIF1001
NIH Device Record Key1f701fa7-572d-4e2e-914d-71cc27303408
Commercial Distribution StatusIn Commercial Distribution
Brand NameTalon DistalFix A/R Femoral Nail Instrument Tray
Version Model NumberODIF100
Catalog NumberODI-F100
Company DUNS945518848
Company NameOrthopedic Designs North America, 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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB058ODIF1001 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


[B058ODIF1001]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-07
Device Publish Date2023-06-29

Devices Manufactured by Orthopedic Designs North America, Inc.

B058AHN5034NS1 - Atlas™ Humeral Nail System2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 034mm (non-sterile)
B058AHN5036NS1 - Atlas™ Humeral Nail System2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 036mm (non-sterile)
B058AHN5038NS1 - Atlas™ Humeral Nail System2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 038mm (non-sterile)
B058AHN5040NS1 - Atlas™ Humeral Nail System2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 040mm (non-sterile)
B058AHN5042NS1 - Atlas™ Humeral Nail System2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 042mm (non-sterile)
B058AHN5044NS1 - Atlas™ Humeral Nail System2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 044mm (non-sterile)
B058AHN5046NS1 - Atlas™ Humeral Nail System2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 046mm (non-sterile)
B058AHN5048NS1 - Atlas™ Humeral Nail System2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 048mm (non-sterile)

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