MONO STAN RF FORCEPS IEC-MJ11

GUDID 00841494104016

MONO STAN RF FORCEPS W/IEC CABLE & VIDEO

Ellman International

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00841494104016
• NIH Device Record Key: 0750d50a-e35e-4381-a7d5-cfc7345b8da3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONO STAN RF FORCEPS
• Version Model Number: IEC-MJ11
• Catalog Number: IEC-MJ11
• 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: 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	00841494104016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964176

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 [MONO STAN RF FORCEPS]

• 00841494104016: MONO STAN RF FORCEPS W/IEC CABLE & VIDEO
• 00841494104009: MONO STAN RF FORCEPS W CABLE & VIDEO CD
• 00841494103996: MINI MONO STAN FORCEPS W CABLE & VIDEOCD