ChitoZolve

GUDID 00821925044166

ChitoZolve Finished Good (8/pk)

Gyrus Acmi, Inc.

Intranasal splint, non-bioabsorbable, animal-derived

• Primary Device ID: 00821925044166
• NIH Device Record Key: 58fff807-a5b8-483a-80a5-1240fa610b5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ChitoZolve
• Version Model Number: CNS155
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 8
• 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: 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	00821925044159 [Primary]
GS1	00821925044166 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181696

FDA Product Code

• LYA: Splint, Intranasal Septal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-11
• Device Publish Date: 2020-12-03

Devices Manufactured by Gyrus Acmi, Inc.

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• 00821925044074 - SOLTIVE: 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 940 Micron
• 00821925002074 - USA Elite System: 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
• 00821925002098 - USA Elite System: 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
• 00821925002111 - USA Elite System: 2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold