| Primary Device ID | 00848665034936 |
| NIH Device Record Key | 4af0f2bd-4c6b-46ff-9201-a04a3caf5532 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OBTURATOR 4.0mm |
| Version Model Number | 4038-000 |
| 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 | false |
| 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 |
| Phone | 310-533-9966 |
| regaffairs@aosortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848665034936 [Primary] |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00848665034936]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-18 |
| Device Publish Date | 2019-11-08 |
| 00848665027679 - COUNTERSINK | 2020-06-23 |
| 00848665000658 - AOS Drill, AO Style, 2.9mm x 100mm | 2020-06-08 |
| 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 |