Monster Screw System P20-170-065M

GUDID 00889795005373

7.0 x 65 mm Headed, Cannulated, Medium Thread Screw

PARAGON 28, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00889795005373
• NIH Device Record Key: 9964fbd6-5d13-4a95-9b05-5d634b7bdabf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monster Screw System
• Version Model Number: P20-170-065M
• Catalog Number: P20-170-065M
• Company DUNS: 042961576
• Company Name: PARAGON 28, 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: 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 Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889795005373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K124027

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00889795005373]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-19
• Device Publish Date: 2016-09-24

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