Olympus

GUDID 00821925045361

Soltive 150 Micron single use ball tip fiber 2.0 (5/PK)

Gyrus ACMI, LLC

General/multiple surgical laser system beam guide, single-use

• Primary Device ID: 00821925045361
• NIH Device Record Key: 07c34619-c060-49f8-9da6-cf4b5fcb97d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olympus
• Version Model Number: TFL-FBX150BSE
• Company DUNS: 007198742
• Company Name: Gyrus ACMI, LLC
• Device Count: 1
• 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	00821925045361 [Package]; Contains: 00821925045378; Package: [5 Units]; In Commercial Distribution
GS1	00821925045378 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2024-10-17
• Device Publish Date: 2024-10-09

On-Brand Devices [Olympus]

• 00821925045583: Soltive 940 Micron reusable fiber 2.0 (5/PK)
• 00821925045569: Soltive 550 Micron reusable fiber 2.0 (5/PK)
• 00821925045545: Soltive 365 Micron reusable fiber 2.0 (5/PK)
• 00821925045521: Soltive 200 Micron reusable fiber 2.0 (5/PK)
• 00821925045507: Soltive 150 Micron reusable fiber 2.0 (5/PK)
• 00821925045484: Soltive 940 Micron single use fiber 2.0 (5/PK)
• 00821925045460: Soltive 550 Micron single use fiber 2.0 (5/PK)
• 00821925045446: Soltive 365 Micron single use fiber 2.0 (5/PK)
• 00821925045408: Soltive 200 Micron single use ball tip fiber 2.0 (5/PK)
• 00821925045385: Soltive 150 Micron single use fiber 2.0 (5/PK)
• 00821925045361: Soltive 150 Micron single use ball tip fiber 2.0 (5/PK)