| Primary Device ID | 00840194466585 |
| NIH Device Record Key | 00aed277-8649-4da3-b680-2eaac35a6278 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PNP TIBIA |
| Version Model Number | 01-1510-0036 |
| Catalog Number | 01-1510-0036 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 00840194466585 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
[00840194466585]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-02 |
| Device Publish Date | 2024-03-25 |
| 00840194466875 | FLEXIBLE IM REAMER SHAFT 25IN |
| 00840194466585 | Large Head Pusher |
| 00840194467162 | 7.0mm MONOBLOC NITINOL REAMER, 635mm |
| 00840194467155 | 6.5mm MONOBLOC NITINOL REAMER, 635mm |
| 00840194467148 | 6.0mm MONOBLOC NITINOL REAMER, 635mm |
| 00840194467131 | 7.0mm MONOBLOC NITINOL REAMER, 435mm |
| 00840194467124 | 6.5mm MONOBLOC NITINOL REAMER, 435mm |
| 00840194467117 | 6.0mm MONOBLOC NITINOL REAMER, 435mm |
| 00840194467100 | NITINOL FLEX SHAFT, 635mm |
| 00840194467094 | NITINOL FLEX SHAFT, 435mm |
| 00840194493895 | 3.2mm x 330mm K-Wire, Threaded, 316L |
| 00840194478366 | PNP Tibia 12mm x 500mm Nail |
| 00840194478359 | PNP Tibia 12mm x 495mm Nail |
| 00840194478342 | PNP Tibia 12mm x 490mm Nail |
| 00840194478335 | PNP Tibia 12mm x 485mm Nail |
| 00840194478328 | PNP Tibia 12mm x 480mm Nail |
| 00840194478311 | PNP Tibia 12mm x 475mm Nail |
| 00840194478304 | PNP Tibia 12mm x 470mm Nail |
| 00840194478298 | PNP Tibia 12mm x 465mm Nail |
| 00840194478281 | PNP Tibia 12mm x 460mm Nail |
| 00840194478274 | PNP Tibia 12mm x 455mm Nail |
| 00840194478267 | PNP Tibia 12mm x 450mm Nail |
| 00840194478250 | PNP Tibia 12mm x 445mm Nail |
| 00840194478243 | PNP Tibia 12mm x 440mm Nail |
| 00840194478236 | PNP Tibia 12mm x 435mm Nail |
| 00840194478229 | PNP Tibia 12mm x 430mm Nail |
| 00840194478212 | PNP Tibia 12mm x 425mm Nail |
| 00840194478205 | PNP Tibia 12mm x 420mm Nail |
| 00840194478199 | PNP Tibia 12mm x 415mm Nail |
| 00840194478182 | PNP Tibia 12mm x 410mm Nail |
| 00840194478175 | PNP Tibia 12mm x 405mm Nail |
| 00840194478168 | PNP Tibia 12mm x 400mm Nail |
| 00840194478151 | PNP Tibia 12mm x 395mm Nail |
| 00840194478144 | PNP Tibia 12mm x 390mm Nail |
| 00840194478137 | PNP Tibia 12mm x 385mm Nail |
| 00840194478120 | PNP Tibia 12mm x 380mm Nail |
| 00840194478113 | PNP Tibia 12mm x 375mm Nail |
| 00840194478106 | PNP Tibia 12mm x 370mm Nail |
| 00840194478090 | PNP Tibia 12mm x 365mm Nail |
| 00840194478083 | PNP Tibia 12mm x 360mm Nail |
| 00840194478076 | PNP Tibia 12mm x 355mm Nail |
| 00840194478069 | PNP Tibia 12mm x 350mm Nail |
| 00840194478052 | PNP Tibia 12mm x 345mm Nail |
| 00840194478045 | PNP Tibia 12mm x 340mm Nail |
| 00840194478038 | PNP Tibia 12mm x 335mm Nail |
| 00840194478021 | PNP Tibia 12mm x 330mm Nail |
| 00840194478014 | PNP Tibia 12mm x 325mm Nail |
| 00840194478007 | PNP Tibia 12mm x 320mm Nail |
| 00840194477994 | PNP Tibia 12mm x 315mm Nail |
| 00840194477987 | PNP Tibia 12mm x 310mm Nail |