SURGITRON 4.0 DUAL RF/90 IEC3A-S30-90/110-USA

GUDID 00841494104887

SURGITRON 4.0 DUAL RF/90 IEC 110V

Ellman International

Electrosurgical system

• Primary Device ID: 00841494104887
• NIH Device Record Key: 220f6832-8a3d-4712-b254-1a1cb79c3c47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGITRON 4.0 DUAL RF/90
• Version Model Number: IEC3A-S30-90/110-USA
• Catalog Number: IEC3A-S30-90/110-USA
• Company DUNS: 079095245
• Company Name: Ellman International
• 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: false
• Serial Number: true
• 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	00841494104887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013255

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [SURGITRON 4.0 DUAL RF/90]

• 00841494106690: SURGITRON 4.0 DUAL RF/90 IEC 110V
• 00841494104887: SURGITRON 4.0 DUAL RF/90 IEC 110V