| Primary Device ID | B058SLNT03031 |
| NIH Device Record Key | 91dd6847-6822-445d-a905-7907fe5f980b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Handle-Arm Connector Screw |
| Version Model Number | SLNT0303 |
| Catalog Number | SLN-T03-03 |
| 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 | B058SLNT03031 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
[B058SLNT03031]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-28 |
| Device Publish Date | 2023-06-20 |
| B058SLNT03031 | Handle-Arm Connector Screw |
| B058ODIT1071 | Handle-Arm Connector Screw |