Ponseti® Plus Abduction Bar

GUDID 00810060880265

Ponseti Plus 13cm 10°

MD ORTHOPAEDICS, INC.

Ankle/foot orthosis

• Primary Device ID: 00810060880265
• NIH Device Record Key: 657c4b32-67b2-4a4a-9766-fbfb8046cdb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ponseti® Plus Abduction Bar
• Version Model Number: PONSETI PLUS 13CM 10
• Company DUNS: 146220269
• Company Name: MD ORTHOPAEDICS, INC.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810060880265 [Primary]

FDA Product Code

• ITN: Splint, Denis Brown

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: 2023-10-20
• Device Publish Date: 2023-10-12

On-Brand Devices [Ponseti® Plus Abduction Bar]

• 00810060880296: Ponseti Plus 14cm 15°
• 00810060880289: Ponseti Plus 14cm 10°
• 00810060880272: Ponseti Plus 13cm 15°
• 00810060880265: Ponseti Plus 13cm 10°
• 00810060880258: Ponseti Plus 12cm 15°
• 00810060880241: Ponseti Plus 12cm 10°
• 00810060880234: Ponseti Plus Short 15
• 00810060880227: Ponseti Plus Short 10°
• 00810060880210: Ponseti Plus Medium 15°
• 00810060880203: Ponseti Plus Medium 10°
• 00810060880197: Ponseti Plus Long 15°
• 00810060880166: Ponseti Plus Long 10°
• 00810060888407: GEARED QUICK CLIP KIT 0°