| Primary Device ID | 00848665033441 |
| NIH Device Record Key | 64053529-2d4d-43b5-8ddc-9f8c8db5dba0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 32mm |
| Version Model Number | 8114-032 |
| Company DUNS | 117858154 |
| Company Name | ADVANCED ORTHOPEDIC SOLUTIONS 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00848665033441 [Primary] |
| HSB | Rod, Fixation, Intramedullary And Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00848665033441]
Moist Heat or Steam Sterilization
[00848665033441]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-05-01 |
| 00848665027679 - COUNTERSINK | 2020-06-23 |
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| 00848665001235 - AOS CANCELLOUS TAP 3.5mm | 2020-06-08 |
| 00848665027624 - SUPRAPATELLAR TIBIAL ENTRY SHEATH | 2020-06-08 |
| 00848665028041 - T10 Screwdriver, Short | 2020-06-08 |
| 00848665028096 - 3.5mm Calibrated Drill | 2020-06-08 |
| 00848665028119 - AOS 2.6mm Solid Reamer | 2020-06-08 |
| 00848665028782 - T10 Screwdriver, Solid | 2020-06-08 |