| Primary Device ID | 00810050250825 |
| NIH Device Record Key | ab4e4b9f-b0e3-4bba-88cf-3041b5139cd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Maramed Orthopedic Systems |
| Version Model Number | PLS-FF-300R |
| Catalog Number | PLS-FF-300R |
| Company DUNS | 926813379 |
| Company Name | BIOSCULPTOR CORPORATION |
| 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com | |
| Phone | 305-823-8300 |
| info@maramed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810050250825 [Primary] |
| OHI | Orthosis, Foot Drop |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-07 |
| Device Publish Date | 2023-11-29 |
| 00810050250849 | The ankle foot orthoses/drop foot splints provide a full foot section for additional support and |
| 00810050250832 | The ankle foot orthoses/drop foot splints provide a full foot section for additional support and |
| 00810050250825 | The ankle foot orthoses/drop foot splints provide a full foot section for additional support and |
| 00810050250818 | The ankle foot orthoses/drop foot splints provide a full foot section for additional support and |
| 00810050250801 | The ankle foot orthoses/drop foot splints provide a full foot section for additional support and |
| 00810050250795 | The ankle foot orthoses/drop foot splints provide a full foot section for additional support and |
| 00810050250788 | The ankle foot orthoses/drop foot splints provide a full foot section for additional support and |
| 00810050250771 | The ankle foot orthoses/drop foot splints provide a full foot section for additional support and |