| Primary Device ID | 00840019926799 |
| NIH Device Record Key | a0060154-c860-437d-87d3-4c18cffa0f1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reform POCT System |
| Version Model Number | 55-IN-0530 |
| Catalog Number | 55-IN-0530 |
| Company DUNS | 079398589 |
| Company Name | PRECISION SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 00840019926799 [Primary] |
| HTW | Bit, Drill |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840019926799]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-04 |
| Device Publish Date | 2019-03-27 |
| 00840019927154 | Add-on Instrument Sterilization Case |
| 00840019927147 | Occipital Rod Caddy |
| 00840019927130 | Occipital Screw Caddy |
| 00840019927123 | Occipital Plate Caddy |
| 00840019927116 | Hook Caddy |
| 00840019927093 | Cross-connector Caddy |
| 00840019927086 | Ø4.0mm Smooth Shank Screw Caddy |
| 00840019927079 | Ø3.5mm Smooth Shank Screw Caddy |
| 00840019927062 | Ø4.5mm Polyaxial Screw Caddy |
| 00840019927055 | Ø4.0mm Polyaxial Screw Caddy |
| 00840019927048 | Ø3.5mm Polyaxial Screw Caddy |
| 00840019927024 | Standard Rod Caddy |
| 00840019927017 | Occipital Instrument Sterilization Case |
| 00840019927000 | Standard Instrument Sterilization Case |
| 00840019926966 | Self-retaining Bone Screw Driver |
| 00840019926959 | Ø3.5mm Coronal Rod Bender, Right |
| 00840019926935 | Inline Counter Torque Wrench Assembly |
| 00840019926928 | Right Angle Counter Torque Wrench |
| 00840019926911 | Right Angle Torque Driver |
| 00840019926898 | Ø4.5mm Duckbill Probe, Straight |
| 00840019926881 | Ø4.0mm Bone Probe, Straight |
| 00840019926874 | Occipital Plate Counter Torque Wrench |
| 00840019926867 | Occipital Rod Bender - Hyperlordotic |
| 00840019926850 | T15 Occipital Screw Driver, Freehand - UV-Joint |
| 00840019926843 | T15 Occipital Screw Driver, Guided - UV-Joint |
| 00840019926836 | T15 Occipital Screw Driver - Straight |
| 00840019926812 | Ø4.5mm Occipital Bone Tap, Guided - UV-Joint |
| 00840019926805 | Ø4.5mm Occipital Bone Tap - Straight |
| 00840019926799 | Ø4.5mm Occipital Bone Drill, Guided - UV-Joint |
| 00840019926782 | Ø4.5mm Occipital Bone Drill - Straight |
| 00840019926775 | Variable Angle Guide |
| 00840019926768 | All-in-one Plate Inserter and Guide |
| 00840019926751 | Occipital Plate Bender |
| 00840019926744 | Occipital Plate Bending Iron Long |
| 00840019926720 | T-Handle Modular Torque Limiting Handle |
| 00840019926713 | Inline Modular Torque Indicating Handle |
| 00840019926706 | Inline Modular Torque Limiting Handle |
| 00840019926683 | Inline Modular Handle, Spin-cap |
| 00840019926676 | Distractor |
| 00840019926669 | Compressor |
| 00840019926652 | Laminar Elevator |
| 00840019926645 | Cross-connector and Domino Inserter |
| 00840019926638 | 55-IN-0136 |
| 00840019926621 | Cross-connector Caliper |
| 00840019926607 | Cross-connector Inserter |
| 00840019926591 | Counter Torque Wrench |
| 00840019926584 | T15 Torque Driver |
| 00840019926577 | Single Sided Cap Screw Retention Driver |
| 00840019926560 | Dual-sided Cap Screw Inserter |
| 00840019926546 | Rod Reduction Rocker |