| Primary Device ID | 00840194415484 |
| NIH Device Record Key | f3b1eaba-a54a-4caf-a238-ae70b97b2105 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pediatric Nailing Platform Femur |
| Version Model Number | 00-1504-1148 |
| Catalog Number | 00-1504-1148 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840194415484 [Primary] |
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840194415484]
Moist Heat or Steam Sterilization
[00840194415484]
Moist Heat or Steam Sterilization
[00840194415484]
Moist Heat or Steam Sterilization
[00840194415484]
Moist Heat or Steam Sterilization
[00840194415484]
Moist Heat or Steam Sterilization
[00840194415484]
Moist Heat or Steam Sterilization
[00840194415484]
Moist Heat or Steam Sterilization
[00840194415484]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2022-09-16 |
| 00840194415620 | 10mm x 20mm End Cap, Retaining |
| 00840194415613 | 10mm x 15mm End Cap, Retaining |
| 00840194415606 | 10mm x 10mm End Cap, Retaining |
| 00840194415590 | 10mm x 5mm End Cap, Retaining |
| 00840194415583 | 10mm x 0mm End Cap, Flush, Retaining |
| 00840194415576 | 12mm x 500mm Adolescent Nail, Right |
| 00840194415569 | 12mm x 480mm Adolescent Nail, Right |
| 00840194415552 | 12mm x 460mm Adolescent Nail, Right |
| 00840194415545 | 12mm x 440mm Adolescent Nail, Right |
| 00840194415538 | 12mm x 500mm Adolescent Nail, Left |
| 00840194415521 | 12mm x 480mm Adolescent Nail, Left |
| 00840194415514 | 12mm x 460mm Adolescent Nail, Left |
| 00840194415507 | 12mm x 440mm Adolescent Nail, Left |
| 00840194415491 | 11mm x 500mm Adolescent Nail, Right |
| 00840194415484 | 11mm x 480mm Adolescent Nail, Right |
| 00840194415477 | 11mm x 460mm Adolescent Nail, Right |
| 00840194415460 | 11mm x 440mm Adolescent Nail, Right |
| 00840194415453 | 11mm x 500mm Adolescent Nail, Left |
| 00840194415446 | 11mm x 480mm Adolescent Nail, Left |
| 00840194415439 | 11mm x 460mm Adolescent Nail, Left |
| 00840194415422 | 11mm x 440mm Adolescent Nail, Left |
| 00840194415415 | 10mm x 500mm Adolescent Nail, Right |
| 00840194415408 | 10mm x 480mm Adolescent Nail, Right |
| 00840194415392 | 10mm x 460mm Adolescent Nail, Right |
| 00840194415385 | 10mm x 440mm Adolescent Nail, Right |
| 00840194415378 | 10mm x 500mm Adolescent Nail, Left |
| 00840194415361 | 10mm x 480mm Adolescent Nail, Left |
| 00840194415354 | 10mm x 460mm Adolescent Nail, Left |
| 00840194415347 | 10mm x 440mm Adolescent Nail, Left |
| 00840194415330 | 9mm x 500mm Adolescent Nail, Right |
| 00840194415323 | 9mm x 480mm Adolescent Nail, Right |
| 00840194415316 | 9mm x 460mm Adolescent Nail, Right |
| 00840194415309 | 9mm x 440mm Adolescent Nail, Right |
| 00840194415293 | 9mm x 500mm Adolescent Nail, Left |
| 00840194415286 | 9mm x 480mm Adolescent Nail, Left |
| 00840194415279 | 9mm x 460mm Adolescent Nail, Left |
| 00840194415262 | 9mm x 440mm Adolescent Nail, Left |
| 00840194415255 | 9mm x 20mm End Cap, Retaining |
| 00840194415248 | 9mm x 15mm End Cap, Retaining |
| 00840194415231 | 9mm x 10mm End Cap, Retaining |
| 00840194415224 | 9mm x 5mm End Cap, Retaining |
| 00840194415217 | 9mm x 0mm End Cap, Flush, Retaining |
| 00840194405669 | 2.0 X 450mm Smooth Wire |
| 00840194405621 | PNP Extraction Chisel |
| 00840194405614 | PNP Adolescent Hook Extractor |
| 00840194405607 | PNP Child Hook Extractor |
| 00840194405577 | PNP Screw Easy Out |
| 00840194405560 | PNP Screw Easy Off |
| 00840194405553 | PNP End Cap Easy Out |
| 00840194405508 | Pedinail Conical Cannulated Extractor - Slap Hammer |