| Primary Device ID | 08057717559538 |
| NIH Device Record Key | d4278498-696a-4270-acac-8e874cb84b64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BRM SILKTOE INSTRUMENT |
| Version Model Number | Multifunctional Silktoe Quick Handle |
| Catalog Number | BRDNPTHANDLE-QK |
| Company DUNS | 435126746 |
| Company Name | BRM EXTREMITIES SRL |
| 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 | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com | |
| Phone | +3903411693087 |
| info@brm-extremities.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature and away from direct sources of light |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08057717559538 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
[08057717559538]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-18 |
| Device Publish Date | 2025-07-10 |
| 08057717559576 | Silktoe 20-30 Cutting Guide |
| 08057717559569 | Silktoe 35 Cutting Guide |
| 08057717559538 | Multifunctional Silktoe Quick Handle |