Olympus

GUDID 00810008185162

ES-IP BASE SYSTEM, SPLIT RACK, FREESTANDING OPTION with Optional Equipment

Gyrus ACMI, LLC

Operating room equipment remote control

• Primary Device ID: 00810008185162
• NIH Device Record Key: 3bdc2039-1ad5-4c98-8ecc-1a07b14b5b78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olympus
• Version Model Number: ISM-1200305
• Company DUNS: 007198742
• Company Name: Gyrus ACMI, LLC
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008185162 [Primary]

FDA Product Code

• FTA: Light, Surgical, Accessories

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: 2025-01-30
• Device Publish Date: 2025-01-22

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