Primary Device ID | B058ODIT1011 |
NIH Device Record Key | 00b631aa-267a-44fe-b273-7eb9e9a97b72 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Guide Handle |
Version Model Number | ODIT101 |
Catalog Number | ODI-T101 |
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 | B058ODIT1011 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
[B058ODIT1011]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-27 |
Device Publish Date | 2023-06-19 |
B058SLNT03021 | Guide Handle |
B058ODIT1011 | Guide Handle |
B058ODIF081 | Guide Handle |