| Primary Device ID | 00815285024111 |
| NIH Device Record Key | 11a1aae8-6a25-41b2-bbf2-2812a33995cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SU-POR Surgical Implant |
| Version Model Number | 4633 |
| Catalog Number | 4633 |
| Company DUNS | 078388975 |
| Company Name | PORIFEROUS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 770-683-3855 |
| info@poriferous.com | |
| Phone | 770-683-3855 |
| info@poriferous.com | |
| Phone | 770-683-3855 |
| info@poriferous.com | |
| Phone | 770-683-3855 |
| info@poriferous.com | |
| Phone | 770-683-3855 |
| info@poriferous.com | |
| Phone | 770-683-3855 |
| info@poriferous.com | |
| Phone | 770-683-3855 |
| info@poriferous.com | |
| Phone | 770-683-3855 |
| info@poriferous.com | |
| Phone | 770-683-3855 |
| info@poriferous.com | |
| Phone | 770-683-3855 |
| info@poriferous.com | |
| Phone | 770-683-3855 |
| info@poriferous.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815285024111 [Primary] |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-09 |
| Device Publish Date | 2022-08-01 |
| 00815285021790 | Nasal Shell - Regular - 38mm x 21mm x 17mm |
| 00815285021783 | Ear Wedge - Left - 15mm x 44mm x 11mm |
| 00815285021776 | Ear Wedge - Right - 15mm x 44mm x 11mm |
| 00815285021769 | Cranial Patient-Specific Implant |
| 00815285021752 | Membrane Sheet - 38mm x 50mm x 0.60mm |
| 00815285021745 | Sellar Floor - Large - Membrane - 40mm x 40mm x 2.5mm x 0.73mm |
| 00815285021738 | Sellar Floor - Regular - 20mm x 20mm x 2.5mm x 0.45mm |
| 00815285021721 | Cranial Hemisphere - Right - 124mm x 170mm x 6.0mm |
| 00815285021714 | Cranial Hemisphere - Left - 124mm x 170mm x 6.0mm |
| 00815285021707 | Cranial Hemisphere - Right - 124mm x 170mm x 4.5mm |
| 00815285021691 | Cranial Hemisphere - Left - 124mm x 170mm x 4.5mm |
| 00815285021684 | Cranial Dome - 150mm x 180mm x 6mm |
| 00815285021677 | Cranial Dome - 150mm x 180mm x 4mm |
| 00815285021660 | Burr Hole Cover - 3 per package - 29mm x 7mm x 14mm |
| 00815285021653 | Burr Hole Cover - 3 per package - 15mm x 3mm x 5mm |
| 00815285021646 | Flex Sheet - with membrane - 56mm x 91mm x 4mm |
| 00815285021639 | Flex Sheet - without membrane - 56mm x 91mm x 4mm |
| 00815285021622 | Temporal Flex Grid - Large - Right - 82mm x 105mm x 20mm |
| 00815285021615 | Temporal Flex Grid - Large - Left - 82mm x 105mm x 20mm |
| 00815285021608 | Temporal Flex Grid - Medium - Right - 74mm x 93mm x 20mm |
| 00815285021592 | Temporal Flex Grid - Medium - Left - 74mm x 93mm x 20mm |
| 00815285021585 | Temporal Flex Grid - Small - Right - 61mm x 78mm x 18mm |
| 00815285021578 | Temporal Flex Grid - Small - Left - 61mm x 78mm x 18mm |
| 00815285021561 | Cranial Flex Grid - 97mm x 106mm x 6mm |
| 00815285021554 | Mastoid - Right - 58mm x 56mm x 1.5mm |
| 00815285021547 | Mastoid - Left- 58mm x 56mm x 1.5mm |
| 00815285021530 | Mastoid - Small - 36mm x 45mm x 1mm |
| 00815285021523 | Pterional - Right - 6mm x 43mm x 44mm |
| 00815285021516 | Pterional - Left - 6mm x 43mm x 44mm |
| 00815285021509 | Nasal Dorsum - Large - 67mm x 9mm x 14mm |
| 00815285021493 | Nasal Dorsum - Small - 54mm x 6mm x 11mm |
| 00815285021486 | Nasal Dorsum - Tapered - 55mm x 6mm x 9mm |
| 00815285021479 | Nasal Arch - 70mm x 17mm x 2mm |
| 00815285021462 | Nasal Arch - 70mm x 15mm x 2mm |
| 00815285021455 | Nasal Arch - 70mm x 13mm x 2mm |
| 00815285021448 | Nasal Radix - 24mm x 3mm x 10mm |
| 00815285021431 | Nasal Sheet - 30mm x 9.0mm x 1.1mm |
| 00815285021424 | Nasal Batten (2 per package) 25mm x 12.5mm x 0.60mm |
| 00815285021417 | Nasal Dorsal Shell - 43mm x 16mm x 22mm |
| 00815285021400 | Block - 38mm x 63mm x 9.5mm |
| 00815285021394 | Block - 25mm x 50mm x 9.5mm |
| 00815285021387 | Block - 13mm x 38mm x 9.5mm |
| 00815285021370 | Block - 38mm x 63mm x 6mm |
| 00815285021363 | Block - 25mm x 50mm x 6mm |
| 00815285021356 | Block - 13mm x 38mm x 6mm |
| 00815285021349 | Block - 38mm x 63mm x 3mm |
| 00815285021332 | Block - 25mm x 50mm x 3mm |
| 00815285021325 | Block - 13mm x 38mm x 3mm |
| 00815285021318 | Auricular Helical Rim - Right - 37mm x 62mm |
| 00815285021301 | Auricular Helical Rim - Left - 37mm x 62mm |