Broken Screw Removal Instruments 01-9200-1035

GUDID 00840194478458

3.5mm Easy Out

ORTHOPEDIATRICS CORP.

Orthopaedic implant inserter/extractor, single-use

• Primary Device ID: 00840194478458
• NIH Device Record Key: 6cddc7c1-35f7-4d3b-897a-f7b82865c6e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Broken Screw Removal Instruments
• Version Model Number: 01-9200-1035
• Catalog Number: 01-9200-1035
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840194478458 [Primary]

FDA Product Code

• GFC: DRIVER, SURGICAL, PIN

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

[00840194478458]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-15
• Device Publish Date: 2024-08-07

On-Brand Devices [Broken Screw Removal Instruments]

• 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