Specialty Instrument SP27-182-0005

GUDID 00889795146625

MIS Chamfer Screw, 5mm Reduction Wire

PARAGON 28, INC.

Orthopaedic guidewire, single-use

• Primary Device ID: 00889795146625
• NIH Device Record Key: 3c29f006-8dd2-46ab-9e14-67ac73007d94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Specialty Instrument
• Version Model Number: SP27-182-0005
• Catalog Number: SP27-182-0005
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• 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: 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	00889795146625 [Primary]

FDA Product Code

• HXI: PASSER, WIRE, ORTHOPEDIC

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: 2025-03-05
• Device Publish Date: 2025-02-25

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