| Primary Device ID | 00841132129258 |
| NIH Device Record Key | 49728228-46d4-4ab8-993c-854257a91ac2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PediNail |
| Version Model Number | 00-1500-5070 |
| Catalog Number | 00-1500-5070 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| 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 | 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 | 00841132129258 [Primary] |
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-31 |
| 00841132136089 | PEDINAIL SCREW CADDY LID |
| 00841132136072 | PEDINAIL SCREW CADDY |
| 00841132135396 | SLAP HAMMER CAP |
| 00841132135389 | SLAP HAMMER ROD |
| 00841132135372 | SLAP HAMMER HANDLE |
| 00841132135365 | MODULAR RETAINING BOLT |
| 00841132135358 | SLAP HAMMER ROD |
| 00841132135341 | A/O QUICK CONNECT END |
| 00841132135334 | SLAP HAMMER HANDLE |
| 00841132135327 | INNER MEASURING DEVICE |
| 00841132135310 | OUTER MEASURING ROD |
| 00841132135303 | 12.0 TISSUE PROTECTOR TUBE |
| 00841132135297 | 10.0 TISSUE PROTECTOR TUBE |
| 00841132135280 | 7.0 TISSUE PROTECTOR TUBE |
| 00841132135273 | GUIDE WIRE/EXCHANGE TUBE BOX |
| 00841132135167 | SCREW CADDY LID |
| 00841132135150 | SCREW CADDY |
| 00841132135143 | PEDINAIL SCREW CADDY (IMPLANT & SCREW CADDY) |
| 00841132135136 | INSTRUMENT INNER TRAY #1 |
| 00841132135129 | INSTRUMENT TRAY #1 |
| 00841132135112 | PEDINAIL INSTRUMENT #1 SET (INSTRUMENT & CASE) |
| 00841132135105 | INSTRUMENT TRAY #2 |
| 00841132135099 | PEDINAIL INSTRUMENT #2 SET (INSTRUMENT & CASE) |
| 00841132135082 | 3.75MM CALIBRATED DRILL BIT |
| 00841132135075 | PEDINAIL X-RAY TEMPLATE PACKAGE LABEL |
| 00841132135068 | PEDINAIL XL IMPLANT TRAY RIGHT |
| 00841132135051 | PEDINAIL XL IMPLANT BASE RIGHT |
| 00841132135044 | PEDINAIL XL IMPLANT TRAY LEFT |
| 00841132135037 | PEDINAIL XL IMPLANT BASE LEFT |
| 00841132135020 | PEDINAIL XL RIGHT IMPLANT SET |
| 00841132135013 | PEDINAIL XL LEFT IMPLANT SET |
| 00841132135006 | PEDINAIL SCREW CADDY |
| 00841132134993 | PEDINAIL IMPLANT INNER TRAY - RIGHT |
| 00841132134986 | PEDINAIL IMPLANT TRAY - RIGHT |
| 00841132134979 | PEDINAIL RIGHT IMPLANT SET (RIGHT IMPLANT & CASE) |
| 00841132134962 | PEDINAIL LEFT IMPLANT SET (LEFT IMPLANT & CASE) |
| 00841132134955 | PEDINAIL IMPLANT INNER TRAY - LEFT |
| 00841132134948 | PEDINAIL IMPLANT TRAY - LEFT |
| 00841132134931 | PEDINAIL INSTRUMENT INNER TRAY #1 |
| 00841132134924 | PEDINAIL INSTRUMENT TRAY #1 |
| 00841132134917 | PEDINAIL CASE LID |
| 00841132134900 | PEDINAIL INSTRUMENT TRAY #2 |
| 00841132129456 | HEADLESS LOCKING BOLT, 60MM |
| 00841132129449 | HEADLESS LOCKING BOLT, 32MM |
| 00841132129432 | HEADLESS LOCKING BOLT, 30MM |
| 00841132129425 | 5.0MM LOCKING BOLT, 98MM |
| 00841132129418 | 5.0MM LOCKING BOLT, 96MM |
| 00841132129401 | 5.0MM LOCKING BOLT, 95MM |
| 00841132129395 | 5.0MM LOCKING BOLT, 94MM |
| 00841132129388 | 5.0MM LOCKING BOLT, 92MM |