| Primary Device ID | 00840194465267 |
| NIH Device Record Key | ae1cb8d3-afa3-46c6-af7a-ec091a47dd0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoPediatrics Hardware Removal |
| Version Model Number | 01-9200-0045 |
| Catalog Number | 01-9200-0045 |
| 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 | 00840194465267 [Primary] |
| KIJ | Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
[00840194465267]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-23 |
| Device Publish Date | 2024-04-15 |
| 00840194466905 | Hardware Removal, Plate & Screw, Upper Tray |
| 00840194466899 | Hardware Removal, Plate & Screw, Case |
| 00840194465304 | Screw Forceps |
| 00840194465298 | Driver, Cannulated 5.0mm Hex |
| 00840194465281 | Driver, Solid 5.0mm Hex |
| 00840194465274 | Driver, Cannulated 4.5mm Hex |
| 00840194465267 | Driver, Solid 4.5mm Hex |
| 00840194465250 | Driver, Cannulated 4.0mm Hex |
| 00840194465243 | Driver, Solid 4.0mm Hex |
| 00840194465236 | Driver, Cannulated 3.5mm Hex |
| 00840194465229 | Driver, Solid 3.5mm Hex |
| 00840194465212 | Driver, Cannulated 3.0mm Hex |
| 00840194465205 | Driver, Solid 3.0mm Hex |
| 00840194465199 | Driver, Cannulated 2.5mm Hex |
| 00840194465182 | Driver, Solid 2.5mm Hex |
| 00840194465168 | Driver, Solid T20 |
| 00840194465151 | Driver, Cannulated T15 |
| 00840194465144 | Driver, Solid T15 |
| 00840194465137 | Driver, Solid T10 |