AcuSect ACS-S50/220-ANZ

GUDID 00841494101794

AcuSect Generator AcuSect Generator

Ellman International

Electrosurgical system generator

• Primary Device ID: 00841494101794
• NIH Device Record Key: a7948061-e4cd-4421-bb21-a7af8a20ee9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcuSect
• Version Model Number: ACS-S50/220-ANZ
• Catalog Number: ACS-S50/220-ANZ
• Company DUNS: 079095245
• Company Name: Ellman International
• Device Count: 1
• DM Exempt: true
• 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	00841494101794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042710

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 [AcuSect]

• 00841494101794: AcuSect Generator AcuSect Generator
• 00841494101787: ACUSECT GENERATOR 110V