| Primary Device ID | 00840019936750 |
| NIH Device Record Key | 8efa02a2-3974-4472-af07-04812dbe2103 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ShurFit ACIF Systems |
| Version Model Number | 45-BK-0101 |
| Catalog Number | 45-BK-0101 |
| Company DUNS | 079398589 |
| Company Name | PRECISION SPINE, INC. |
| 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 | 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 | 00840019936750 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840019936750]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-09-03 |
| 00840019908092 | 10° X 12mm Implant |
| 00840019908085 | 10° X 11mm Implant |
| 00840019908078 | 10° X 10mm Implant |
| 00840019908061 | 10° X 9mm Implant |
| 00840019908054 | 10° X 8mm Implant |
| 00840019908047 | 10° X 7mm Implant |
| 00840019908030 | 10° X 6mm Implant |
| 00840019908023 | 10° X 5mm Implant |
| 00840019908016 | 5° X 12mm Implant |
| 00840019908009 | 5° X 11mm Implant |
| 00840019907996 | 5° X 10mm Implant |
| 00840019907989 | 5° X 9mm Implant |
| 00840019907972 | 5° X 8mm Implant |
| 00840019907965 | 5° X 7mm Implant |
| 00840019907958 | 5° X 6mm Implant |
| 00840019907941 | 5° X 5mm Implant |
| 00840019936750 | Implant Kit |