| Primary Device ID | 08057717550832 |
| NIH Device Record Key | 11a5912a-9992-4fdd-b979-663ff1ac5391 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silktoe Spacer |
| Version Model Number | SIZE 30 RIGHT |
| Catalog Number | BRDNEWP3030R |
| Company DUNS | 435126746 |
| Company Name | BRM EXTREMITIES SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08057717550832 [Primary] |
| KWH | Prosthesis, Toe, Constrained, Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-25 |
| Device Publish Date | 2021-10-17 |
| 08057717550894 | SIZE 50 RIGHT |
| 08057717550887 | SIZE 50 LEFT |
| 08057717550870 | SIZE 40 RIGHT |
| 08057717550863 | SIZE 40 LEFT |
| 08057717550856 | SIZE 35 RIGHT |
| 08057717550849 | SIZE 35 LEFT |
| 08057717550832 | SIZE 30 RIGHT |
| 08057717550825 | SIZE 30 LEFT |
| 08057717550818 | SIZE 20 RIGHT |
| 08057717550801 | SIZE 20 LEFT |