| Primary Device ID | 08057717559699 |
| NIH Device Record Key | 6499f9d5-b47e-485f-aef3-c384e3794f31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SILKTOE INSTRUMENT |
| Version Model Number | 40-50 SILKTOE PHALANGEAL GROMMETS IMPACTOR |
| Catalog Number | BRDNPTI4050D |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| 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 | |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08057717559699 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
[08057717559699]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-11 |
| Device Publish Date | 2022-03-03 |
| 08057717559743 | INSTRUMENTS SET |
| 08057717559804 | 20-30 SILKTOE PHALANGEAL RASP |
| 08057717559798 | 20-30 SILKTOE METATARSAL RASP |
| 08057717559781 | 35 SILKTOE PHALANGEAL RASP |
| 08057717559774 | 35 SILKTOE METATARSAL RASP |
| 08057717559767 | 40-50 SILKTOE PHALANGEAL RASP |
| 08057717559750 | 40-50 SILKTOE METATARSAL RASP |
| 08057717559736 | 20-30 SILKTOE PHALANGEAL GROMMETS IMPACTOR |
| 08057717559729 | 20-30 SILKTOE METATARSAL GROMMETS IMPACTOR |
| 08057717559712 | 35 SILKTOE PHALANGEAL GROMMETS IMPACTOR |
| 08057717559705 | 35 SILKTOE METATARSAL GROMMETS IMPACTOR |
| 08057717559699 | 40-50 SILKTOE PHALANGEAL GROMMETS IMPACTOR |
| 08057717559682 | 40-50 SILKTOE METATARSAL GROMMETS IMPACTOR |
| 08057717553796 | SILKTOE MULTIFUNCTIONAL HANDLE |
| 08057717559651 | 40 Right Silktoe Trial Sizer (Blue) |
| 08057717559675 | 50 Right Silktoe Trial Sizer (Red) |
| 08057717559644 | 40 Left Silktoe Trial Sizer (Blue) |
| 08057717559408 | Quick Connection Type-S |
| 08057717559668 | 50 Left Silktoe Trial Sizer (Red) |
| 08057717559637 | 35 Right Silktoe Trial Sizer (Yellow) |
| 08057717559620 | 35 Left Silktoe Trial Sizer (Yellow) |
| 08057717559613 | 30 Right Silktoe Trial Sizer (Orange) |
| 08057717559606 | 30 Left Silktoe Trial Sizer (Orange) |
| 08057717559590 | 20 Right Silktoe Trial Sizer (Green) |
| 08057717559583 | 20 Left Silktoe Trial Sizer (Green) |
| 08057717559552 | Silktoe 40-50 Cutting Guide |
| 08057717559521 | Silktoe 20-30 Metatarsal Quick Rasp |
| 08057717559514 | Silktoe 20-30 Phalangeal Quick Rasp |
| 08057717559507 | Silktoe 35 Metatarsal Quick Rasp |
| 08057717559491 | Silktoe 40-50 Metatarsal Quick Rasp |
| 08057717559484 | Silktoe 35 Phalangeal Quick Rasp |
| 08057717559477 | Silktoe 40-50 Phalangeal Quick Rasp |
| 08057717559460 | Silktoe 20-30 Metatarsal Grommet Quick Impactor |
| 08057717559453 | Silktoe 35 Metatarsal Grommet Quick Impactor |
| 08057717559446 | Silktoe 40-50 Metatarsal Grommet Quick Impactor |
| 08057717559439 | Silktoe 20-30 Phalangeal Grommet Quick Impactor |
| 08057717559422 | Silktoe 35 Phalangeal Grommet Quick Impactor |
| 08057717559415 | Silktoe 40-50 Phalangeal Grommet Quick Impactor |
| 08057717559392 | Quick Adapter type-C |
| 08057717559385 | Silktoe Sterilization Quick Tray |
| 08057717551303 | Silktoe Sterilization tray |
| 08057717551273 | Silktoe Handle Sliding Unit |
| 08053782780327 | Silktoe Cutting Guide holder |