| Primary Device ID | 00815285022049 |
| NIH Device Record Key | 178b665d-90ca-4a5d-a597-1e48641f6eb3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Su-Por Surgical Implants |
| Version Model Number | 4461 |
| Catalog Number | 4461 |
| Company DUNS | 078388975 |
| Company Name | PORIFEROUS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815285022049 [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 | 2022-03-08 |
| Device Publish Date | 2022-02-28 |
| 00815285023114 | Burr Hole Cover Large - 1 Per Package |
| 00815285023107 | Burr Hole Cover Small - 1 Per Package |
| 00815285023190 | Posterior Fossa Plate - Large 55.0mm x 45.0mm x 1.6mm |
| 00815285023183 | Posterior Fossa Plate - Medium 47.0mm x 40.0mm x 1.6mm |
| 00815285023176 | Special Capocelli Plate with Cut Guide 50mm x 27mm x 3mm |
| 00815285023145 | Supraorbital Eyebrow Closure - Right 34.0mm x 55.0mm x 3.0mm |
| 00815285023138 | Supraorbital Eyebrow Closure - Left 34.0mm x 55.0mm x 3.0mm |
| 00815285023121 | Mastoid Large 63mm x 55.2mm x 1.0mm |
| 00815285023091 | Retrosigmoid - Left 32.2mm x 35mm x 1.6mm |
| 00815285023084 | Retrosigmoid - Right 32.2mm x 35mm x 1.6mm |
| 00815285021875 | Conical Orbital Implant 7.4ml Volume - 22mm Diameter |
| 00815285023206 | Retrosigmoid - Large - Right - 58mm x 52.60mm x 1.60mm |
| 00815285022940 | High-Definition Block - 38mm x 63mm x 9.5mm |
| 00815285022438 | Lower Eyelid Spacer w Superior Strip – Large – 43mm x 22mm x 0.45mm |
| 00815285022391 | Fan Plate w Membrane 40 mm Radius - 1.0mm w Template 40mm Radius x 34 mm x 1.0mm |
| 00815285022384 | 4 Fan Plate 40mm Radius - 1.5mm w Template 40mm Radius x 34 mm x 1.5mm |
| 00815285022377 | 4487 |
| 00815285022360 | Orbital Floor Plate w Membrane – Large – 1.0 - 35mm x 35mm x 1.0mm |
| 00815285022353 | Orbital Floor Plate w Membrane - Medium – 1.0 - 30mm x 30mm x 1.0mm |
| 00815285022346 | Orbital Floor Plate w Membrane – Small – 1.0 - 24mm x 24mm x 1.0mm |
| 00815285022339 | Orbital Floor Plate - Large 35mm x 35mm x 1.5mm |
| 00815285022322 | Orbital Floor Plate - Medium 30mm x 30mm x 1.5mm |
| 00815285022315 | Orbital Floor Plate - Small 24mm x 24mm x 1.5mm |
| 00815285022308 | Orbital Floor Plate - Large 35mm x 35mm x 0.85mm |
| 00815285022292 | Orbital Floor Plate - Medium 30 x 30 x 0.85mm |
| 00815285022285 | Orbital Floor Plate - Small 24mm x 24mm x 0.85mm |
| 00815285022162 | Lower Eyelid Spacer - superior strip – 29.5mm x 9mm x 0.45mm |
| 00815285022155 | Lower Eyelid Spacer -29.5mm x 9mm x 0.45mm |
| 00815285022148 | Ear Wedge Thin - Right - 15mm x 44mm x 11mm |
| 00815285022131 | Ear Wedge Thin - Left - 15mm x 44mm x 11mm |
| 00815285022124 | 3D Orbital Floor - Large – Left - 34mm x 37.5mm x 16mm |
| 00815285022117 | 3D Orbital Floor - Large – Right - 34mm x 37.5mm x 16mm |
| 00815285022087 | 3D Orbital Floor - Small - Left - 30mm x 35mm x 13mm |
| 00815285022070 | 3D Orbital Floor - Small – Right - 30mm x 35mm x 13mm |
| 00815285022063 | Capocelli Plate - Large - 54mm x 45mm x 3mm |
| 00815285022056 | Capocelli Plate - Medium - 48mm x 40mm x 3mm |
| 00815285022049 | Capocelli Plate - Small - 43mm x 36mm x 3mm |
| 00815285022032 | Airo - Large - Qty 2 - 21mm x 9.5mm x 0.45mm |
| 00815285022025 | Airo - Small - Qty 2 - 10mm x 5.0mm x 0.45mm |
| 00815285022018 | Airo - Large - Qty 1 - 21mm x 9.5mm x 0.45mm |
| 00815285022001 | Airo - Small - Qty 1 - 10mm x 5.0mm x 0.45mm |
| 00815285021998 | Occipital Implant 114mm x 101mm x 6mm |
| 00815285021981 | Pterional - SMOOTH - Right - 49mm x 46mm x 2mm |
| 00815285021974 | Pterional - SMOOTH - Left - 49mm x 46mm x 2mm |
| 00815285021967 | Petite Nasal Dorsum - 6mm x 9mm x 55mm |
| 00815285021950 | Petite Nasal Dorsum - 5mm x 5mm x 55mm |
| 00815285021943 | Petite Nasal Dorsum - 5mm x 5mm x 45mm |
| 00815285021936 | Petite Nasal Dorsum - 4mm x 4mm x 55mm |
| 00815285021929 | Petite Nasal Dorsum - 4mm x 4mm x 45mm |
| 00815285021912 | Nasal Onlay 41mm x 3.1mm x 9mm |