FastClamp - FastClamp System

GUDID 05051986011622

Extended Clamp Arm assy

SURGICAL INNOVATIONS LIMITED

Medical table clamp

• Primary Device ID: 05051986011622
• NIH Device Record Key: 7c3baf95-c077-4df0-9793-d515c509d568
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FastClamp - FastClamp System
• Version Model Number: IC-1001-01
• Company DUNS: 771051935
• Company Name: SURGICAL INNOVATIONS LIMITED
• 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: false
• 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	05051986011622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100442

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[05051986011622]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-31
• Device Publish Date: 2017-10-13

On-Brand Devices [FastClamp - FastClamp System]

• 05051986011622: Extended Clamp Arm assy
• 05051986011608: FastClamp Bariatric Bar
• 05051986011592: FastClamp Bar 700mm
• 05051986011578: FastClamp Bar 500mm
• 05051986011547: FastClamp Bar 300mm
• 05051986011530: Bariatric Fastclamp
• 05051986006628: Instrument Clamp Assembly
• 05051986006574: Table Clamp
• 05051986001210: FastClamp