Monkey Rings External Fixation System P45-194-2040

GUDID 00889795115263

Wire, Ø2.0 x 400 Smooth, Half Point

PARAGON 28, INC.

Orthopaedic bone wire

• Primary Device ID: 00889795115263
• NIH Device Record Key: 4acbd116-00d4-460c-a984-3ed0340be8b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monkey Rings External Fixation System
• Version Model Number: P45-194-2040
• Catalog Number: P45-194-2040
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	00889795115263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212895

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

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: 2023-04-04
• Device Publish Date: 2023-03-27

On-Brand Devices [Monkey Rings External Fixation System]

• 00889795124326: Drill Guide for 6mm Half Pin Drill
• 00889795124319: Drill Guide for 5mm Half Pin Drill
• 00889795124302: Drill Guide for 4mm Half Pin Drill
• 00889795116468: Ratchet Wrench, 10mm (OIC wrench)
• 00889795115287: Wire, Ø2.0 x 400 Reduction, Half Point
• 00889795115263: Wire, Ø2.0 x 400 Smooth, Half Point