Olympus

GUDID 00821925045712

TFL Fiber Stripper 150 Micron Non-Sterile, Single Use Soltive

Gyrus ACMI, LLC

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

• Primary Device ID: 00821925045712
• NIH Device Record Key: 448cedb7-ff32-4809-be69-25652136504e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olympus
• Version Model Number: TFL-AFS150-NS
• 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: true
• Expiration Date: false
• 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	00821925045712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242191

FDA Product Code

• GEX: Powered Laser 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: 2025-03-04
• Device Publish Date: 2025-02-24

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)
• 00821925046252: UDI, Digital Hub, ES-IP, MD
• 00821925046221: ES-IP Integrated Operating Room Controller DIGITAL HUB, ES-IP
• 00821925038868: PK ADVANCED INTERGRATED MULTIFUNCTIONAL DEVICE (5/PK, For use with ESG 400 Generator Only)
• 00821925046245: UDI, Digital Hub, ES-IP
• 00821925046504: ES-IP BASE SWIVEL IN-ROOM with Optional Equipment
• 00821925046481: ES-IP BASE EXPANDED SWIVEL IN-ROOM with Optional Equipment
• 00810008185759: ES-IP Dual IN-ROOM System - Expanded with Optional Equipment
• 00810008185278: ES-IP EXPANDED IN-ROOM System 25RU with Optional Equipment
• 00810008185261: ES-IP Dual IN-ROOM System with Optional Equipment
• 00810008185162: ES-IP BASE SYSTEM, SPLIT RACK, FREESTANDING OPTION with Optional Equipment
• 00810008185155: ES-IP BASE SYSTEM, SPLIT RACK, THREE ROOM with Optional Equipment
• 00810008185148: ES-IP BASE SYSTEM, SPLIT RACK, TWO ROOM with Optional Equipment
• 00810008185131: ES-IP BASE SWIVEL IN-ROOM with Optional Equipment
• 00810008184615: ES-IP Base IN-ROOM System with Optional Equipment
• 00821925045750: TFL Fiber Stripper 940 Micron Non-Sterile, Single Use Soltive
• 00821925045743: TFL Fiber Stripper 550 Micron Non-Sterile, Single Use Soltive
• 00821925045736: TFL Fiber Stripper 365 Micron Non-Sterile, Single Use Soltive
• 00821925045729: TFL Fiber Stripper 200 Micron Non-Sterile, Single Use Soltive
• 00821925045712: TFL Fiber Stripper 150 Micron Non-Sterile, Single Use Soltive
• 00821925045699: TFL Fiber Cleaver Non-Sterile, Single Use Soltive (5/PK)
• 00821925047082: nCare 4K Audio Cables
• 00821925047075: nCare 4K Footswitch
• 00821925046610: nCare 4K Keyboard, All-in-one, Compact, Medical, Washable, USB, White
• 00821925046290: Medical Video Recorder Digital Hub, nCare 4K, MD
• 00821925046283: nCare 4K Accessories
• 00821925046276: Medical Video Recorder Digital Hub, nCare 4K
• 00821925046269: Medical Video Recorder Digital Hub, nCare 4K and Accessories
• 00821925045996: nCare 4K Cable Assembly, 1694F, 3G-SDI, 4K BNC Male to Male, 6 ft. or (1.83 m), Black
• 00821925045989: nCare 4K Cable, DisplayPort to HDMI, 6ft or (1.83 m), C2G, 54326
• 00821925045965: nCare 4K Cable Assembly, HDMI M to DVI-D M, Single Link, Black, 6 ft. or (1.83 m)
• 00821925045958: nCare 4K Cable Assembly, DVI-D to DVI-D, Single Link TMDS, Black, 6.0 ft. or (1.83 m)
• 00821925045941: nCare 4K 21.5" Medical Touch Panel
• 00821925047327: ES-IP iOR Danderyd Small (no rack)
• 00821925047310: ES-IP iOR System - Mali
• 00821925047303: ISM-1200635
• 00821925047297: ES-IP iOR Danderyd Large (with rack)
• 00821925047280: ES-IP iOR BWK Hamburg Hybrid (no rack)
• 00821925047273: ES-IP iOR BWK Hamburg OP (no rack)
• 00821925047266: ES-IP iOR BWK Hamburg OP (with rack)