PolyPrep CD-PP-4000-S

GUDID 00840124514195

Push Pull

FUSION ORTHOPEDICS, LLC

Orthopaedic fixation plate file/rasp

• Primary Device ID: 00840124514195
• NIH Device Record Key: 6dd95a70-c59e-475c-9957-a158dcff99fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyPrep
• Version Model Number: CD-PP-4000-S
• Catalog Number: CD-PP-4000-S
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840124514195 [Primary]

FDA Product Code

• QBO: Instruments Designed For Press-Fit Osteochondral Implants

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-05
• Device Publish Date: 2024-10-28

Devices Manufactured by FUSION ORTHOPEDICS, LLC

• 00840124514195 - PolyPrep: 2024-11-05Push Pull
• 00840124514195 - PolyPrep: 2024-11-05 Push Pull
• 00840124514201 - FuzeFix Chamfered Screws: 2024-11-05 Manual Rasp Mirror
• 00840124514218 - PolyLock Midfoot: 2024-11-05 Distractor Compressor
• 00840124509405 - FuzeFix Jones: 2024-10-22 K-Wire Standard 1.6mm
• 00840124514102 - FuzeFix Chamfered Screws: 2024-10-14 Chamfered Screw Tray
• 00840124514096 - PolyLock Midfoot: 2024-10-09 Plate Bending Iron
• 00840124513754 - PolyLock Midfoot: 2024-10-07 MTP Prime Plate Universal Revision
• 00840124513761 - PolyLock Midfoot: 2024-10-07 MTP Prime Plate Short Left Revision