Monkey Rings External Fixation System P45-513-0010

GUDID 00889795116468

Ratchet Wrench, 10mm (OIC wrench)

PARAGON 28, INC.

Surgical torque wrench, reusable

• Primary Device ID: 00889795116468
• NIH Device Record Key: 536f2abc-364a-4dfa-a3bf-b824f25595bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monkey Rings External Fixation System
• Version Model Number: P45-513-0010
• Catalog Number: P45-513-0010
• Company DUNS: 042961576
• Company Name: PARAGON 28, 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: 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	00889795116468 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

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