Response 4.5/5.0, Response 5.5/6.0 G202500_B

GUDID 00841132185186

Rod Template Trial 5mm Nitinol Rod Silicone Sleeve 500mm Length Black

ORTHOPEDIATRICS CORP.

Surgical implant template, reusable

• Primary Device ID: 00841132185186
• NIH Device Record Key: 546a8501-a78a-407f-a443-eb12786bb790
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response 4.5/5.0, Response 5.5/6.0
• Version Model Number: G202500_B
• Catalog Number: G202500_B
• 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

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132185186 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

[00841132185186]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-25
• Device Publish Date: 2024-10-17

On-Brand Devices [Response 4.5/5.0, Response 5.5/6.0]

• 00841132185186: Rod Template Trial 5mm Nitinol Rod Silicone Sleeve 500mm Length Black
• 00841132185179: Rod Template Trial 3.2mm Nitinol Rod Silicone Sleeve 500mm Length Blue