| Primary Device ID | 00841132144718 |
| NIH Device Record Key | 8c919da4-1e65-411b-b80a-954fa3cdd004 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PediFragment |
| Version Model Number | 01-1005-1019 |
| Catalog Number | 01-1005-1019 |
| 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 |
| Rzorn@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 | |
| 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 | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841132144718 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
[00841132144718]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-08-30 |
| 00841132135952 | PEDIFRAG FRAGMENT SYSTEM 2.7/3.5 - BASE |
| 00841132135945 | PEDIFRAG FRAGMENT SYSTEM 2.7/3.5 - 3.5 TRAY |
| 00841132133699 | PEDILOC FRAGMENT SYSTEM 2.7 3.5 |
| 00841132133682 | PEDILOC FRAGMENT SYSTEM 4.5 - SCREW CADDY LID |
| 00841132133675 | PEDILOC FRAGMENT SYSTEM 4.5 - SCREW CADDY |
| 00841132133668 | PEDILOC FRAGMENT SYSTEM 4.5 - 4.5 TRAY |
| 00841132133651 | PEDILOC FRAGMENT SYSTEM 2.7/3.5 - BASE |
| 00841132133644 | PEDILOC FRAGMENT SYSTEM 2.7/3.5 - 3.5 TRAY |
| 00841132133637 | PEDILOC FRAGMENT SYSTEM 2.7/3.5 - 2.7 TRAY |
| 00841132133620 | PEDILOC FRAGMENT SYSTEM 2.7/3.5 - SCREW CADDY LID |
| 00841132133613 | PEDILOC FRAGMENT SYSTEM 2.7/3.5 - SCREW CADDY |
| 00841132133606 | PEDILOC FRAGMENT SYSTEM 2.7/3.5 |
| 00841132133590 | PROVISIONAL REDUCTION DEVICE, SLEEVE, SMALL |
| 00841132133583 | PROVISIONAL REDUCTION DEVICE. SHAFT, SMALL |
| 00841132146088 | WRIST FUSION CASE LID |
| 00841132146071 | WRIST FUSION CASE BASE |
| 00841132146064 | 2.7MM/3.5MM WRIST FUSION PLATE BENDING TEMPLATE, 99MM |
| 00841132144718 | CLAVICLE PLATE LID |
| 00841132144701 | CLAVICLE PLATE CASE |
| 00841132144695 | WRIST FUSION CASE LID |
| 00841132144688 | WRIST FUSION CASE BASE |
| 00841132144671 | 2.7MM/3.5MM WRIST FUSION PLATE BENDING TEMPLATE, 99MM |
| 00841132144640 | 3.5MM CLAVICLE PLATE, 7 HOLE, LEFT |
| 00841132144633 | 3.5MM CLAVICLE PLATE, 5 HOLE, LEFT |
| 00841132144626 | 3.5MM CLAVICLE PLATE, 7 HOLE, RIGHT |
| 00841132144619 | 3.5MM CLAVICLE PLATE, 5 HOLE, RIGHT |
| 00841132144602 | 3.5MM CLAVICLE PLATE, 10 HOLE, LEFT |
| 00841132144596 | 3.5MM CLAVICLE PLATE, 8 HOLE, LEFT |
| 00841132144589 | 3.5MM CLAVICLE PLATE, 6 HOLE, LEFT |
| 00841132144572 | 3.5MM CLAVICLE PLATE, 4 HOLE, LEFT |
| 00841132144565 | 3.5MM CLAVICLE PLATE, 10 HOLE, RIGHT |
| 00841132144558 | 3.5MM CLAVICLE PLATE, 8 HOLE, RIGHT |
| 00841132144541 | 3.5MM CLAVICLE PLATE, 6 HOLE, RIGHT |
| 00841132144534 | 3.5MM CLAVICLE PLATE, 4 HOLE, RIGHT |
| 00841132144527 | 2.7MM CLAVICLE PLATE, 7 HOLE, LEFT |
| 00841132144510 | 2.7MM CLAVICLE PLATE, 5 HOLE, LEFT |
| 00841132144503 | 2.7MM CLAVICLE PLATE, 7 HOLE, RIGHT |
| 00841132144497 | 2.7MM CLAVICLE PLATE, 5 HOLE, RIGHT |
| 00841132144480 | 2.7MM CLAVICLE PLATE, 10 HOLE, LEFT |
| 00841132144473 | 2.7MM CLAVICLE PLATE, 8 HOLE, LEFT |
| 00841132144466 | 2.7MM CLAVICLE PLATE, 6 HOLE, LEFT |
| 00841132144459 | 2.7MM CLAVICLE PLATE, 4 HOLE, LEFT |
| 00841132144442 | 2.7MM CLAVICLE PLATE, 10 HOLE, RIGHT |
| 00841132144435 | 2.7MM CLAVICLE PLATE, 8 HOLE, RIGHT |
| 00841132144428 | 2.7MM CLAVICLE PLATE, 6 HOLE, RIGHT |
| 00841132144411 | 2.7MM CLAVICLE PLATE, 4 HOLE, RIGHT |