| Primary Device ID | 00088466000529 |
| NIH Device Record Key | 73923458-8ced-493c-a976-fc5e55788c0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Superion Indirect Decompression System |
| Version Model Number | 8mm |
| Catalog Number | 101-9808 |
| Company DUNS | 005235436 |
| Company Name | VERTIFLEX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | true |
| OTC Over-The-Counter | false |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00088466000529 [Primary] |
| NQO | Prosthesis, Spinous Process Spacer/Plate |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-07 |
| Device Publish Date | 2019-02-04 |
| 00884662000567 | Superion Indirect Decompression System, 16mm |
| 00884662000550 | Superion Indirect Decompression System, 14mm |
| 00884662000543 | Superion Indirect Decompression System, 12mm |
| 00884662000536 | Superion Indirect Decompression System, 10mm |
| 00088466000529 | Superion Indirect Decompression System, 8mm |
| 00884662000529 | Superion Indirect Decompression System, 8mm |