Fastclamp

GUDID 05051986011561

FASTCLAMP SYSTEM FastClamp Bar 300mm Medical Table Clamp

SURGICAL INNOVATIONS LIMITED

Medical table clamp

• Primary Device ID: 05051986011561
• NIH Device Record Key: b259b55f-c9e0-4060-98f2-88f6daa0522e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fastclamp
• Version Model Number: BC-1030-02
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051986011561 [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

[05051986011561]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-13

On-Brand Devices [Fastclamp]

• 05051986011639: FASTCLAMP SYSTEM Extended Clamp Arm assy Medical Table Clamp
• 05051986011615: FASTCLAMP SYSTEM FastClamp Bariatric Bar Medical Table Clamp
• 05051986011585: FASTCLAMP SYSTEM FastClamp Bar 500mm Medical Table Clamp
• 05051986011561: FASTCLAMP SYSTEM FastClamp Bar 300mm Medical Table Clamp
• 05051986006642: FASTCLAMP SYSTEM FastClamp Medical Table Clamp
• 05051986006635: FASTCLAMP SYSTEM Instrument Clamp Assembly Medical Table Clamp
• 05051986006581: FASTCLAMP SYSTEM Table Clamp Medical Table Clamp