| Primary Device ID | 10812269025000 |
| NIH Device Record Key | 60a99f1e-f2db-47f9-a3a2-066542e42bc8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polyaxial Drill Guide Screw, 2.0T |
| Version Model Number | MDS190801 |
| Catalog Number | MDS190801 |
| Company DUNS | 078703080 |
| Company Name | MIAMI DEVICE SOLUTIONS LLC |
| 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 | true |
| 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 |
| Phone | 786-422-1400 |
| customerservice@miamidevicesolutions.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10812269025000 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10812269025000]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2018-12-17 |
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