| Primary Device ID | 00852578008267 |
| NIH Device Record Key | efc47014-2011-49ba-b8d2-fcb64f1e9a0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OmniPore Surgical Implant |
| Version Model Number | OP8337 |
| Company DUNS | 079634199 |
| Company Name | MATRIX SURGICAL HOLDINGS, LLC |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852578008267 [Primary] |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
[00852578008267]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-15 |
| Device Publish Date | 2023-08-07 |
| 90852578008000 | InvisiShunt Kit (OP1001/OP1002) |
| 00855421005970 | OmniPore Surgical Implant |
| 00852578008182 | InvisiShunt Kit (OP5001/OP5002) |
| 00852578008168 | InvisiShunt Implant |
| 00852578008090 | InvisiShunt Kit (OP4001/OP4002) |
| 00852578008076 | OmniPore Surgical Implant |
| 00852578008069 | InvisiShunt Implant Kit |
| 00852578008045 | InvisiShunt Implant |
| 00852578008038 | InvisiShunt Kit (OP2001/OP2002) |
| 00852578008014 | InvisiShunt Implant |
| 00855421005963 | Burr Hole Cover |
| 00855421005956 | Burr Hole Cover |
| 00855421005826 | Bendblock Implant |
| 00855421005352 | Block |
| 00855421005345 | Block |
| 00855421005338 | Block |
| 00855421005321 | Block |
| 00855421005314 | Block |
| 00855421005307 | Block |
| 00855421005161 | Orbital Sphere |
| 00855421005154 | Orbital Sphere |
| 00855421005147 | Orbital Sphere |
| 00855421005130 | Orbital Sphere |
| 00855421005123 | Orbital Sphere |
| 00855421005048 | Sheet |
| 00855421005031 | Sheet |
| 00855421005024 | Ultra Thin Sheet |
| 00855421005000 | Ultra Thin Sheet |
| 00855421005840 | Design Y™ Inferior Orbital Rim - Right |
| 00855421005833 | Design Y™ Inferior Orbital Rim - Left |
| 00855421005574 | Design Y™ Malar - Small -Left |
| 00855421005567 | Design Y™ Malar - Small - Right |
| 00855421005949 | CHANNEL Sheet |
| 00855421005895 | Large Paranasal - Right |
| 00855421005888 | Large Paranasal - Left |
| 00855421005871 | Petite Paranasal - Right |
| 00855421005864 | Petite Paranasal - Left |
| 00855421005857 | Extended Orbital Rim - Left |
| 00855421005819 | BENDBLOCK™ TF2 Large - Right |
| 00855421005802 | BENDBLOCK™ TF2 Large - Left |
| 00855421005796 | BENDBLOCK™ TF2 Medium - Right |
| 00855421005789 | BENDBLOCK™ TF2 Medium - Left |
| 00855421005772 | BENDBLOCK™ TF2 Small - Right |
| 00855421005765 | BENDBLOCK™ TF2 Small - Left |
| 00855421005758 | BENDBLOCK™ Cranial Grid Implant |
| 00855421005741 | Cranial Hemisphere - Left |
| 00855421005734 | Cranial Hemisphere - Right |
| 00855421005635 | Pterional Implant - Left |
| 00855421005628 | Pterional Implant - Right |
| 00855421005611 | Design Y™ Malar - Large - Left |