| Primary Device ID | 00884662000147 |
| NIH Device Record Key | bf8a1f73-0444-467b-9fc9-d69e55fed3cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Superion Grasping Forceps |
| Version Model Number | N/A |
| Catalog Number | 100-9112 |
| Company DUNS | 005235436 |
| Company Name | VERTIFLEX, INC. |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884662000147 [Primary] |
| NQO | Prosthesis, Spinous Process Spacer/Plate |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
[00884662000147]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-08-16 |
| 00884662000529 - Superion Indirect Decompression System | 2020-10-06 Superion Indirect Decompression System, 8mm |
| 00884662000574 - Superion IDS Kit | 2019-07-25 Superion IDS Kit includes a Driver (102-9108), Inserter (102-9110), & Interspinous Gauge (102-9115) |
| 00884662000611 - Vertiflex Instrument Platform | 2019-07-25 Vertiflex Instrument Platform includes a Dilator Assembly (140-9501), Cannula Assembly (140-9502), & Reamer (140-9503) |
| 00088466000529 - Superion Indirect Decompression System | 2019-03-07 Superion Indirect Decompression System, 8mm |
| 00884662000536 - Superion Indirect Decompression System | 2019-03-07 Superion Indirect Decompression System, 10mm |
| 00884662000543 - Superion Indirect Decompression System | 2019-03-07 Superion Indirect Decompression System, 12mm |
| 00884662000550 - Superion Indirect Decompression System | 2019-03-07 Superion Indirect Decompression System, 14mm |
| 00884662000567 - Superion Indirect Decompression System | 2019-03-07 Superion Indirect Decompression System, 16mm |