| Primary Device ID | 00840194480260 |
| NIH Device Record Key | 0a7b082e-1f10-4f23-b53d-314eeae4e794 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Broken Screw Removal Instruments |
| Version Model Number | 01-9200-0203 |
| Catalog Number | 01-9200-0203 |
| 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 | true |
| 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 | 00840194480260 [Primary] |
| GFC | DRIVER, SURGICAL, PIN |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
[00840194480260]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-15 |
| Device Publish Date | 2024-08-07 |
| 00840194480772 | Plate & Screw Hardware Removal, Lower Tray |
| 00840194480291 | Over-the-Head Screw Extractor, 9.75mm |
| 00840194480284 | Over-the-Head Screw Extractor, 8.75mm |
| 00840194480277 | Over-the-Head Screw Extractor, 7.75mm |
| 00840194480260 | Over-the-Head Screw Extractor, 6.75mm |
| 00840194480253 | Over-the-Head Screw Extractor, 5.75mm |
| 00840194480246 | Over-the-Head Screw Extractor, 4.85mm |
| 00840194478496 | 5.5mm Easy Out |
| 00840194478489 | 5.0mm Easy Out |
| 00840194478472 | 4.5mm Easy Out |
| 00840194478465 | 4.0mm Easy Out |
| 00840194478458 | 3.5mm Easy Out |
| 00840194478441 | 3.0mm Easy Out |
| 00840194478434 | 2.5mm Easy Out |
| 00840194478427 | 2.0mm Easy Out |
| 00840194478410 | 1.5mm Easy Out |