| Primary Device ID | 00860011634836 |
| NIH Device Record Key | 16d31d1e-d758-4e41-b920-dab24c0e4c9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurePass CTR NS Blade |
| Version Model Number | CT-2003NS |
| Company DUNS | 119211016 |
| Company Name | Dev4 |
| 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 | false |
| 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 | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com | |
| Phone | 832-257-0845 |
| jeff@dev-4.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860011634836 [Primary] |
| GS1 | 10860011634833 [Package] Package: [10 Units] In Commercial Distribution |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
[00860011634836]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-28 |
| Device Publish Date | 2025-05-20 |
| 00860011634829 - SurePass CTR NS Guide | 2025-05-28 Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Guide |
| 00860011634836 - SurePass CTR NS Blade | 2025-05-28Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade |
| 00860011634836 - SurePass CTR NS Blade | 2025-05-28 Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade |