Guide Arm ODI-T103

GUDID B058ODIT1031

Guide Arm

Orthopedic Designs North America, Inc.

Orthopaedic implant aiming arm
Primary Device IDB058ODIT1031
NIH Device Record Key4473ef84-4a24-4c8d-a054-d39bf76f80b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuide Arm
Version Model NumberODIT103
Catalog NumberODI-T103
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 Numberfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB058ODIT1031 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


[B058ODIT1031]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-22
Device Publish Date2023-06-14

On-Brand Devices [Guide Arm]

B058ODIT1031Guide Arm
B058ODIF121Guide Arm
B058SLNT03011Guide Arm

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