DF2 03-DF2B-0054

GUDID 00840194471862

Cool Foam Pad, Left, L

ORTHOPEDIATRICS CORP.

Multiple-joint lower limb orthosis

• Primary Device ID: 00840194471862
• NIH Device Record Key: e2d5aed7-9df6-423e-9c46-922cf6559ecf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DF2
• Version Model Number: 03-DF2B-0054
• Catalog Number: 03-DF2B-0054
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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	00840194471862 [Primary]

FDA Product Code

• IQI: ORTHOSIS, LIMB BRACE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-18
• Device Publish Date: 2024-07-10

On-Brand Devices [DF2]

• 00840194471930: Cool Foam Pad, Right, XXL
• 00840194471916: Cool Foam Pad, Left, XXL
• 00840194471909: Cool Foam Pad, Right, XL
• 00840194471893: Cool Foam Pad, Left, XL
• 00840194471879: Cool Foam Pad, Right, L
• 00840194471862: Cool Foam Pad, Left, L
• 00840194471855: Cool Foam Pad, Right, M
• 00840194471831: Cool Foam Pad, Left, M
• 00840194471824: Cool Foam Pad, Right, S
• 00840194471817: Cool Foam Pad, Left, S
• 00840194471794: Cool Foam Pad, Right, XS
• 00840194471787: Cool Foam Pad, Left, XS