| Primary Device ID | 00840194478557 |
| NIH Device Record Key | 55f69667-1207-45c3-9967-8680bc602f75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gen II Cannulated Screws |
| Version Model Number | 01-1400-0241 |
| Catalog Number | 01-1400-0241 |
| 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 | 00840194478557 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840194478557]
Moist Heat or Steam Sterilization
[00840194478557]
Moist Heat or Steam Sterilization
[00840194478557]
Moist Heat or Steam Sterilization
[00840194478557]
Moist Heat or Steam Sterilization
[00840194478557]
Moist Heat or Steam Sterilization
[00840194478557]
Moist Heat or Steam Sterilization
[00840194478557]
Moist Heat or Steam Sterilization
[00840194478557]
Moist Heat or Steam Sterilization
[00840194478557]
Moist Heat or Steam Sterilization
[00840194478557]
Moist Heat or Steam Sterilization
[00840194478557]
Moist Heat or Steam Sterilization
[00840194478557]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-02 |
| Device Publish Date | 2024-07-25 |
| 00840194478557 | 3x3 Wire Guide, 2.0/2.5mm |
| 00840194478540 | 3x3 Wire Guide, 1.25/1.6mm |