Monopolar scissors

GUDID 04714127862989

UNIMAX MEDICAL SYSTEMS INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 04714127862989
• NIH Device Record Key: ecbb35cd-0e28-4160-86a6-9e369c6057eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monopolar scissors
• Version Model Number: FMS445055
• Company DUNS: 658122465
• Company Name: UNIMAX MEDICAL SYSTEMS INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04714127862989 [Primary]
GS1	14714127862986 [Package]; Package: box [10 Units]; In Commercial Distribution
GS1	24714127862983 [Package]; Contains: 14714127862986; Package: carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103508

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-17
• Device Publish Date: 2018-02-06

On-Brand Devices [Monopolar scissors]

• 24714127868466: FMS333057
• 24714127867124: FMS333054
• 24714127865984: FMS333050
• 24714127862990: FMS433055
• 04714127862989: FMS445055
• 24714127862976: FMS433056