Special Instrument SP99-150-CO10

GUDID 00889795153616

Special Instrument, Calc Slide Obturator, 10mm

Paragon 28, Inc.

Surgical drill guide obturator

• Primary Device ID: 00889795153616
• NIH Device Record Key: 1bc39789-9da9-4d51-9dec-103d80fb4ef5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Special Instrument
• Version Model Number: SP99-150-CO10
• Catalog Number: SP99-150-CO10
• 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	00889795153616 [Primary]

FDA Product Code

• FZX: Guide, 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: 2025-10-07
• Device Publish Date: 2025-09-29

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• 00889795153616: Special Instrument, Calc Slide Obturator, 10mm