Primary Device ID | 00841132122662 |
NIH Device Record Key | 47c8d1c4-2ec6-4baf-b49f-6bc5f826a90d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PediFrag |
Version Model Number | 01-1005-0032 |
Catalog Number | 01-1005-0032 |
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 | 00841132122662 [Primary] |
LXH | Orthopedic manual surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
[00841132122662]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-01-01 |
Device Publish Date | 2023-12-22 |
00841132138380 | 3.5MM CLAVICLE PLATE, 5 HOLE, LEFT |
00841132138373 | 3.5MM CLAVICLE PLATE, 7 HOLE, RIGHT |
00841132138366 | 3.5MM CLAVICLE PLATE, 5 HOLE, RIGHT |
00841132138359 | 3.5MM CLAVICLE PLATE, 10 HOLE, LEFT |
00841132138342 | 3.5MM CLAVICLE PLATE, 8 HOLE, LEFT |
00841132138335 | 3.5MM CLAVICLE PLATE, 6 HOLE, LEFT |
00841132138328 | 3.5MM CLAVICLE PLATE, 4 HOLE, LEFT |
00841132138311 | 3.5MM CLAVICLE PLATE, 10 HOLE, RIGHT |
00841132138304 | 3.5MM CLAVICLE PLATE, 8 HOLE, RIGHT |
00841132138298 | 3.5MM CLAVICLE PLATE, 6 HOLE, RIGHT |
00841132138281 | 3.5MM CLAVICLE PLATE, 4 HOLE, RIGHT |
00841132138274 | 2.7MM CLAVICLE PLATE, 7 HOLE, LEFT |
00841132138267 | 2.7MM CLAVICLE PLATE, 5 HOLE, LEFT |
00841132138250 | 2.7MM CLAVICLE PLATE, 7 HOLE, RIGHT |
00841132138243 | 2.7MM CLAVICLE PLATE, 5 HOLE, RIGHT |
00841132138236 | 2.7MM CLAVICLE PLATE, 10 HOLE, LEFT |
00841132138229 | 2.7MM CLAVICLE PLATE, 8 HOLE, LEFT |
00841132138212 | 2.7MM CLAVICLE PLATE, 6 HOLE, LEFT |
00841132138205 | 2.7MM CLAVICLE PLATE, 4 HOLE, LEFT |
00841132138199 | 2.7MM CLAVICLE PLATE, 10 HOLE, RIGHT |
00841132138182 | 2.7MM CLAVICLE PLATE, 8 HOLE, RIGHT |
00841132138175 | 2.7MM CLAVICLE PLATE, 6 HOLE, RIGHT |
00841132138168 | 2.7MM CLAVICLE PLATE, 4 HOLE, RIGHT |
00841132137239 | PEDIFRAG SMALL AND MINI FRAGMENT SYSTEM (2.7/3.5/4.0) BOM |
00841132130452 | PEDILOC FRAGMENT SYSTEM 2.7/3.5- 2.7 TRAY, SMALL |
00841132130445 | PEDILOC FRAGMENT SYSTEM SCREW CADDY LID |
00841132130438 | PEDILOC FRAGMENT SYSTEM SCREW CADDY |
00841132130421 | PEDILOC FRAGMENT SYSTEM 2.7/3.5- 3.5 TRAY, SMALL |
00841132130414 | PEDILOC FRAGMENT SYSTEM 2.7/3.5- 2.7 TRAY, SMALL |
00841132130407 | PEDIFRAG TRAY, BASE |
00841132138410 | CLAVICLE PLATE LID |
00841132138403 | CLAVICLE PLATE TRAY |
00841132122716 | T10 RETAINING DRIVER, SHORT |
00841132122709 | T10 HEXALOBE DRIVER, SHORT |
00841132122662 | T15 CANNULATED DRIVER, SHORT (DIA 1.25) |
00841132122655 | 2.5 MM X 150 MM GUIDE WIRE, THREADED |
00841132122648 | PLATE FIXATION PIN |
00841132122631 | T15 HEXALOBE DRIVER, RETAINING |
00841132122624 | T10 HEXALOBE DRIVER, RETAINING |
00841132122617 | CANNULATED COUNTERSINK |
00841132122600 | 3.5 MM DRILL BIT |
00841132122594 | 2.7 MM DRILL BIT |
00841132122587 | 2.0 MM CALIBRATED DRILL BIT |
00841132122570 | 2.0 MM DRILL BIT |
00841132138397 | 3.5MM CLAVICLE PLATE, 7 HOLE, LEFT |