Primary Device ID | 00841132136072 |
NIH Device Record Key | 8c4b02b7-830b-45c8-82cb-6bc8e51b75d5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PediNail |
Version Model Number | 01-1500-9321 |
Catalog Number | 01-1500-9321 |
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 |
Phone | +1(574)268-6379 |
Rbremer@orthopediatrics.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841132136072 [Primary] |
FSM | TRAY, SURGICAL, INSTRUMENT |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-02-15 |
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 |