Response 5.5, Response 5.5/6.0 01-1300-8730

GUDID 00840194478526

Extended Mini-Reducer Locking Derotation Handle

ORTHOPEDIATRICS CORP.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00840194478526
• NIH Device Record Key: 9bce91c2-3d58-4c58-ae1f-935ffa017371
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response 5.5, Response 5.5/6.0
• Version Model Number: 01-1300-8730
• Catalog Number: 01-1300-8730
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840194478526 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840194478526]

Moist Heat or Steam Sterilization

[00840194478526]

Moist Heat or Steam Sterilization

[00840194478526]

Moist Heat or Steam Sterilization

[00840194478526]

Moist Heat or Steam Sterilization

[00840194478526]

Moist Heat or Steam Sterilization

[00840194478526]

Moist Heat or Steam Sterilization

[00840194478526]

Moist Heat or Steam Sterilization

[00840194478526]

Moist Heat or Steam Sterilization

[00840194478526]

Moist Heat or Steam Sterilization

[00840194478526]

Moist Heat or Steam Sterilization

[00840194478526]

Moist Heat or Steam Sterilization

[00840194478526]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-15
• Device Publish Date: 2024-07-05

On-Brand Devices [Response 5.5, Response 5.5/6.0]

• 00840194487450: Extended Mini-Reducer Wing Nut
• 00840194478533: Extended Mini-Reducer Handle
• 00840194478526: Extended Mini-Reducer Locking Derotation Handle
• 00840194478519: 5.5/6.0 Extended Mini-Reducer
• 00840194478397: Extended Mini-Reducer - Tray 2
• 00840194478380: Extended Mini-Reducer - Tray 1
• 00840194480239: Counter Torque - Extended Mini-Reducer
• 00840194493918: Extended Mini-Reducer Long Handle