| Primary Device ID | 00860011634812 |
| NIH Device Record Key | 3e077c58-dd93-4fde-aef1-8f473f6bdff5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurePass CTR |
| Version Model Number | CT-1000 |
| Company DUNS | 119211016 |
| Company Name | Extremity Concepts LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860011634812 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
[00860011634812]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-01 |
| Device Publish Date | 2024-03-22 |
| 00860011634805 - TrapEZ | 2024-04-01 Small Bone Extraction Tool |
| 00860011634812 - SurePass CTR | 2024-04-01Carpal Tunnel Release, (1) SurePass CTR Guide, (1) SurePass CTR Knife Blade |
| 00860011634812 - SurePass CTR | 2024-04-01 Carpal Tunnel Release, (1) SurePass CTR Guide, (1) SurePass CTR Knife Blade |