Primary Device ID | B058ODIT1361 |
NIH Device Record Key | f91dcab9-297e-45a5-941e-8dcfbb3823e4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Compression Nut Driver |
Version Model Number | ODIT136 |
Catalog Number | ODI-T136 |
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 | false |
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 | B058ODIT1361 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
[B058ODIT1361]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-10 |
Device Publish Date | 2023-06-30 |
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) |
B058AHN5042NS1 - Atlas™ Humeral Nail System | 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 042mm (non-sterile) |
B058AHN5044NS1 - Atlas™ Humeral Nail System | 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 044mm (non-sterile) |
B058AHN5046NS1 - Atlas™ Humeral Nail System | 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 046mm (non-sterile) |
B058AHN5048NS1 - Atlas™ Humeral Nail System | 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 048mm (non-sterile) |