| Primary Device ID | 09353903012573 |
| NIH Device Record Key | 26970f9d-d1ea-4b21-8c04-8e461df18875 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FO NX Nail System |
| Version Model Number | APN000269 |
| Catalog Number | KWDT-10150/5 |
| Company DUNS | 744008914 |
| Company Name | FIELD ORTHOPAEDICS PTY LTD |
| Device Count | 5 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09353903012474 [Unit of Use] |
| GS1 | 09353903012573 [Primary] |
| HTY | Pin, Fixation, Smooth |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
[09353903012573]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-31 |
| Device Publish Date | 2022-10-21 |
| 09353903013273 | 5.0 NX Extremity System Tray and Lid 1/pkg |
| 09353903013266 | 4.0 NX Extremity System Tray and Lid 1/pkg |
| 09353903013259 | 3.5 NX Extremity System Tray and Lid 1/pkg |
| 09353903013242 | 3.0 NX Extremity System Tray and Lid 1/pkg |
| 09353903013235 | 2.5 NX Extremity System Tray and Lid 1/pkg |
| 09353903013228 | 2.0 NX Extremity System Tray and Lid 1/pkg |
| 09353903012719 | 5.0 NX Nail System Tray 1/pkg |
| 09353903012702 | 4.0 NX Nail System Tray 1/pkg |
| 09353903012696 | 3.5 NX Nail System Tray 1/pkg |
| 09353903012689 | 3.0 NX Nail System Tray 1/pkg |
| 09353903012672 | 2.5 NX Nail System Tray 1/pkg |
| 09353903012665 | 2.0 NX Nail System Tray 1/pkg |
| 09353903012658 | NX Nail System Lid 1/pkg |
| 09353903012627 | 1.8 Double-ended Trocar K-wire 150 mm 5/pkg |
| 09353903012610 | 1.6 Double-ended Trocar K-wire 150 mm 5/pkg |
| 09353903012603 | 1.4 Double-ended Trocar K-wire 150 mm 5/pkg |
| 09353903012597 | 1.2 Double-ended Trocar K-wire 150 mm 5/pkg |
| 09353903012580 | 1.2 Double-ended Trocar K-wire 100 mm 5/pkg |
| 09353903012573 | 1.0 Double-ended Trocar K-wire 150 mm 5/pkg |
| 09353903012566 | 1.0 Double-ended Trocar K-wire 100 mm 5/pkg |
| 09353903012559 | 0.8 Double-ended Trocar K-wire 100 mm 5/pkg |
| 09353903012542 | 0.8 Double-ended Trocar K-wire 70 mm 5/pkg |
| 09353903012535 | 0.6 Double-ended Trocar K-wire 70 mm 5/pkg |
| 09353903009719 | T8 Cannulated Torx Driver 1/pkg |
| 09353903009696 | T20 Cannulated Torx Driver 1/pkg |
| 09353903009689 | T15 Cannulated Torx Driver 1/pkg |
| 09353903009672 | T10 Cannulated Torx Driver 1/pkg |
| 09353903009573 | 5.0 NX Extremity Nail 90 mm 1/pkg |
| 09353903009566 | 5.0 NX Extremity Nail 80 mm 1/pkg |
| 09353903009559 | 5.0 NX Extremity Nail 70 mm 1/pkg |
| 09353903009542 | 5.0 NX Extremity Nail 60 mm 1/pkg |
| 09353903009535 | 5.0 NX Extremity Nail 55 mm 1/pkg |
| 09353903009528 | 5.0 NX Extremity Nail 50 mm 1/pkg |
| 09353903009511 | 5.0 NX Extremity Nail 45 mm 1/pkg |
| 09353903009504 | 5.0 NX Extremity Nail 40 mm 1/pkg |
| 09353903009498 | 4.0 NX Extremity Nail 80 mm 1/pkg |
| 09353903009481 | 4.0 NX Extremity Nail 70 mm 1/pkg |
| 09353903009474 | 4.0 NX Extremity Nail 60 mm 1/pkg |
| 09353903009467 | 4.0 NX Extremity Nail 55 mm 1/pkg |
| 09353903009450 | 4.0 NX Extremity Nail 50 mm 1/pkg |
| 09353903009443 | 4.0 NX Extremity Nail 45 mm 1/pkg |
| 09353903009436 | 4.0 NX Extremity Nail 40 mm 1/pkg |
| 09353903009429 | 3.5 NX Extremity Nail 70 mm 1/pkg |
| 09353903009412 | 3.5 NX Extremity Nail 60 mm 1/pkg |
| 09353903009405 | 3.5 NX Extremity Nail 55 mm 1/pkg |
| 09353903009399 | 3.5 NX Extremity Nail 50 mm 1/pkg |
| 09353903009382 | 3.5 NX Extremity Nail 45 mm 1/pkg |
| 09353903009375 | 3.5 NX Extremity Nail 40 mm 1/pkg |
| 09353903009368 | 3.0 NX Extremity Nail 70 mm 1/pkg |
| 09353903009351 | 3.0 NX Extremity Nail 60 mm 1/pkg |