| Primary Device ID | 00866453000109 |
| NIH Device Record Key | fbc24132-ddb6-456b-9e71-fedbc805a39c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearShield (Non-Sterile) |
| Version Model Number | IMP |
| Company DUNS | 858769651 |
| Company Name | Osteosymbionics, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00866453000109 [Primary] |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00866453000109]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-26 |
| 00866453000109 - ClearShield (Non-Sterile) | 2018-07-06PMMA Patient Specific Cranial Implant (Non-Sterile) |
| 00866453000109 - ClearShield (Non-Sterile) | 2018-07-06 PMMA Patient Specific Cranial Implant (Non-Sterile) |
| 00866453000123 - PK Shield | 2018-07-06 PEEK Patient Specific Cranial Implant |
| 00866453000130 - ST Temporalis | 2018-07-06 Silicone Temporal Implant - Small |
| 00866453000147 - ST Temporalis | 2018-07-06 Silicone Temporal Implant - Large |
| 00866453000116 - ClearShield (Sterile) | 2018-03-29 PMMA Patient Specific Cranial Implant (Sterile) |