| Primary Device ID | 00840019905398 |
| NIH Device Record Key | bfa429d9-7488-46d2-a194-7998d4d318dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureLOK MIS 3L |
| Version Model Number | 63-CP-5525 |
| Catalog Number | 63-CP-5525 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840019905398 [Primary] |
| MNI | Orthosis, Spinal Pedicle Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840019905398]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-16 |
| Device Publish Date | 2019-04-08 |
| 00840019960403 - ShurFit Lumbar Interbody | 2024-04-23 Curved Cage Implant Inserter |
| 00840019930932 - Reform POCT System | 2024-04-17 Ø3.5 x 34mm Polyaxial Screw - M/L Bias |
| 00840019930949 - Reform POCT System | 2024-04-17 Ø3.5 x 36mm Polyaxial Screw - M/L Bias |
| 00840019930956 - Reform POCT System | 2024-04-17 Ø3.5 x 38mm Polyaxial Screw - M/L Bias |
| 00840019930963 - Reform POCT System | 2024-04-17 Ø4.0 x 32mm Polyaxial Screw - M/L Bias |
| 00840019930970 - Reform POCT System | 2024-04-17 Ø4.0 x 34mm Polyaxial Screw - M/L Bias |
| 00840019930987 - Reform POCT System | 2024-04-17 Ø4.0 x 36mm Polyaxial Screw - M/L Bias |
| 00840019930994 - Reform POCT System | 2024-04-17 Ø4.0 x 38mm Polyaxial Screw - M/L Bias |