ACL 01-1008-2530

GUDID 00841132124277

2.5MM X 300MM GUIDE WIRE, SMOOTH, COCR

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132124277
• NIH Device Record Key: 4b4c536c-07c8-43c9-afcf-c431b689994c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACL
• Version Model Number: 01-1008-2530
• Catalog Number: 01-1008-2530
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132124277 [Primary]

FDA Product Code

• FZH: Apparatus, air handling, room

Sterilization

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

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

[00841132124277]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-14
• Device Publish Date: 2021-07-06

Devices Manufactured by ORTHOPEDIATRICS CORP.

• 00840194478373 - Response Spine System: 2025-01-23 Double Action Rod Shears
• 00840194493543 - Response Spine System: 2024-11-20 Atlanta Correction – Tray 1
• 00840194493550 - Response Spine System: 2024-11-20 Atlanta Correction – Tray 2
• 00840194493567 - Response Spine System: 2024-11-20 Atlanta Correction – Tray 3
• 00840194493574 - Response Spine System: 2024-11-20 Atlanta Prep – Tray 1
• 00840194493581 - Response Spine System: 2024-11-20 Atlanta Prep – Tray 2
• 00840194493598 - Response Spine System: 2024-11-20 Atlanta Prep – Tray 3
• 00840194493604 - Response Spine System: 2024-11-20 Atlanta Extras – Tray 1