| Primary Device ID | B058ODIT1451 |
| NIH Device Record Key | 3de090a0-a319-44ab-99e3-365adbc4ca8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CCD Instrument Tray |
| Version Model Number | ODIT145 |
| Catalog Number | ODI-T145 |
| Company DUNS | 945518848 |
| Company Name | Orthopedic Designs North America, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B058ODIT1451 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
[B058ODIT1451]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-07 |
| Device Publish Date | 2023-06-29 |
| B058AHN08255L1 - Atlas™ Humeral Nail System | 2025-06-25 Atlas Humeral Nail System - Nail Ø8mm | 255mm | Left |
| B058AHN08255R1 - Atlas™ Humeral Nail System | 2025-06-25 Atlas Humeral Nail System - Nail Ø8mm | 255mm | Right |
| B058AHN08270L1 - Atlas™ Humeral Nail System | 2025-06-25 Atlas Humeral Nail System - Nail Ø8mm | 270mm | Left |
| B058AHN08270R1 - Atlas™ Humeral Nail System | 2025-06-25 Atlas Humeral Nail System - Nail Ø8mm | 270mm | Right |
| B058AHN5034NS1 - Atlas™ Humeral Nail System | 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 034mm (non-sterile) |
| B058AHN5036NS1 - Atlas™ Humeral Nail System | 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 036mm (non-sterile) |
| B058AHN5038NS1 - Atlas™ Humeral Nail System | 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 038mm (non-sterile) |
| B058AHN5040NS1 - Atlas™ Humeral Nail System | 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 040mm (non-sterile) |