PDO Max Threads PDO-SC-BL-02

GUDID 00850018324663

Duo Molded 420mm Sterile Inner

Max Pdo Inc

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 00850018324663
• NIH Device Record Key: e4bf570e-8474-409c-882c-6d29f4db6b91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PDO Max Threads
• Version Model Number: PDO-SC-BL-02
• Catalog Number: PDO-SC-BL-02
• Company DUNS: 043570058
• Company Name: Max Pdo Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018324663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190245

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

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: 2022-07-28
• Device Publish Date: 2022-07-20

On-Brand Devices [PDO Max Threads]

• 00850018324458: Multi-Thread 23gx60mm Foil Pack
• 00850018324441: Multi-Thread 23gx38mm Foil Pack
• 00850018324434: Molded Levo 18gx100mm Foil Pack
• 00850018324427: Molded Levo 19gx100mm Foil Pack
• 00850018324410: Levo 18gx60mm Foil Pack
• 00850018324403: Levo 19gx60mm Foil Pack
• 00850018324397: Ciclone 26gx38mm Foil Pack
• 00850018324380: Smuth B 23gx60mm Foil Pack
• 00850018324373: Smuth B 29gx25mm Foil Pack
• 00850018324366: Smuth B 30gx38mm Foil Pack
• 00850018324359: Smuth B 29x38mm Foil Pack
• 00850018324342: Smuth S 26gx60mm Foil Pack
• 00850018324335: Smuth S 29gx50mm Foil Pack
• 00850018324328: Smuth S 30gx25mm Foil Pack
• 00850018324311: Smuth S 30gx38mm Foil Pack
• 00850018324304: Levo 19gx100mm Foil Pack
• 00850018324298: Levo 18gx100mm Foil Pack
• 00850018324281: Levo 21gx100mm Foil Pack
• 00850018324274: Levo 23gx60mm Foil Pack
• 00850018324267: Levo 19gx50mm Nose Foil Pack
• 00850018324250: Double Ciclone 26gx38mm Foil Pack
• 00850018324243: Levo 19gx38mm Nose Foil Pack
• 00850018324236: Levo 19gx50mm Nose Sterile Inner
• 00850018324229: Levo 19gx38mm Nose Sterile Inner
• 00850018324212: Multi-Thread 23gx60mm Sterile Inner
• 00850018324205: Multi-Thread 23gx38mm Sterile Inner
• 00850018324199: Double Ciclone 26gx38mm Sterile Inner
• 00850018324182: Molded Levo 18gx100mm Sterile Inner
• 00850018324175: Molded Levo 19gx100mm Sterile Inner
• 00850018324168: Levo 18gx60mm Sterile Inner
• 00850018324151: Levo 19gx60mm Sterile Inner
• 00850018324144: Ciclone 26gx38mm Sterile Inner
• 00850018324137: Smuth B 23gx60mm Sterile Inner
• 00850018324120: Smuth B 29gx25mm Sterile Inner
• 00850018324113: Smuth B 29gx38mm Sterile Inner
• 00850018324106: Smuth S 26gx60mm Sterile Inner
• 00850018324090: Smuth S 29gx50mm Sterile Inner
• 00850018324083: Smuth S 30gx25mm Sterile Inner
• 00850018324076: Smuth S 30gx38mm Sterile Inner
• 00850018324069: Levo 19gx100mm Sterile Inner
• 00850018324052: Levo 18gx100mm Sterile Inner
• 00850018324045: Levo 21gx100mm Sterile Inner
• 00850018324038: Levo 23gx60mm Sterile Inner
• 00850018324021: Smuth B 30gx38mm Sterile Inner
• 00850018324595: Molded Levo Max 19gx100mm Foil Pack
• 00850018324588: Molded Levo Max 19gx100mm Sterile Inner
• 00850018324571: Molded Levo Max 18gx100mm Foil Pack
• 00850018324564: Molded Levo Max 18gx100mm Sterile Inner
• 00850018324557: Double Ciclone 25gx60mm Foil Pack
• 00850018324540: Double Ciclone 25gx60mm Sterile Inner