| Primary Device ID | 10850030914146 |
| NIH Device Record Key | 03253eed-876d-439c-b183-f04452c654ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | E.Z.4641-NB |
| Catalog Number | NB-M0020058 |
| Company DUNS | 118104014 |
| Company Name | Microport Navibot International LLC |
| 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 | false |
| Serial Number | true |
| 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 | 00850030914149 [Primary] |
| GS1 | 10850030914146 [Package] Contains: 00850030914149 Package: Box [1 Units] In Commercial Distribution |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
[10850030914146]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-08-25 |
| Device Publish Date | 2022-12-08 |
| 00850030914064 | Tunnel Guide |
| 00850030914040 | Fixation Component |
| 10850030914283 | Nail Pouched |
| 10850030914276 | Long Pin Pouched |
| 10850030914269 | Standard Pin Pouched |
| 10850030914146 | Knee Kit Sterilization Tray |
| 00850030914118 | Osteotomy Probe Probe L Type |
| 00850030914255 | Marker Box (40) |
| 00850030914248 | Leg Positioner |
| 00850030914231 | Leg Positioner Base Plate and Clamp |
| 00850030914224 | Base Plate and Clamp Sterilization Tray |
| 00850030914217 | Leg Positioner Clamp |
| 00850030914200 | Leg Positioner Base Plate |
| 00850030914194 | Leg Positioner Adjustable Plate & Boot |
| 00850030914187 | Leg Positioner Sterilization Tray |
| 00850030914170 | Leg Positioner Boot |
| 00850030914163 | Leg Positioner Adjustable Plate |
| 00850030914156 | Knee Kit |
| 00850030914132 | Blunted Probe Bracket |
| 00850030914125 | Pointed Probe Bracket |
| 00850030914101 | Calibration Probe Bracket |
| 00850030914095 | Base Probe Bracket |
| 00850030914088 | Tibia Probe Bracket |
| 00850030914071 | Femur Probe Bracket |
| 00850030914057 | Wrench |
| 00850030914033 | Cutting Block w/Tool Probe |
| 00850030914026 | Robotic Arm & Accessories |
| 10850030914016 | Surgical Console |
| 10850030914009 | Navigation Trolley Assembly |